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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03677336
Other study ID # DYDRA001
Secondary ID 2018-000105-23
Status Completed
Phase Phase 4
First received
Last updated
Start date May 1, 2019
Est. completion date August 24, 2020

Study information

Verified date December 2020
Source CRG UZ Brussel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Female inability to conceive a child. The purpose of this prospective randomized, double-blinded, double dummy, two-arm cross-over study is to investigate the difference on histological, transcriptional and immunological level in endometrium between 3x10mg Dydrogesterone oral tablets and 3x200 mg Micronized progesterone intravaginal capsules for the luteal support in egg cell donors. Beside that, the pharmacokinetics, the impact on the peripheral immunology (by blood sampling) and the microbiota (by genital swabs) will be investigated.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 24, 2020
Est. primary completion date August 24, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Oocyte donor candidates - Regularly cycling - BMI =18 and = 29 kg/m2 - Signed informed consent - Non-smokers. - AMH <7,53 and >1,18 ng/mL (90th and 10th percentile for healthy women aged 25-29 according to the used Elecsys® AMH kit by Roche) - PRL, T and TSH within the normal limits for the clinical laboratory, or considered not clinically significant by the investigator within 6 months prior or at screening Exclusion Criteria: - Intra-uterine device - Previous enrollment - Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, HEENT (head, ears, eyes, nose, throat), dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurologic/psychiatric, allergy, recent major surgery (< 3 months), or other relevant diseases as revealed by history, physical examination and/or laboratory assessments which could limit participation in or completion of the study - Acute urogenital disease during the course of the study - Known allergic reactions to progesterone / dydrogesterone products (active substance or to any of the excipients) - Intake of any experimental drug or any participation in any other clinical trial within 30 days prior to study start. - Mental disability or any other lack of fitness, in the investigator's opinion, to preclude subjects in or to complete the study. - Current or recent substance abuse, including alcohol and tobacco (patients who stopped tobacco usage at least 3 months prior to screening visit would be allowed) - Refusal or inability to comply with the requirements of the study protocol for any reason, including scheduled clinic visits and laboratory tests. - Known or suspected progestogen dependent neoplasms (e.g. meningioma) - Serum progesterone level >1.5 ng/mL at ovulation triggering

Study Design


Intervention

Drug:
Dydrogesterone Oral Tablet
Tablet, oral, 10 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days
Micronized progesterone
Capsule, vaginal, 200 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days
Placebo Dydrogesterone oral tablet
Tablet, indistinguishable from dydrogesterone oral tablet
Placebo Micronized progesterone
Capsule, indistinguishable from micronized vaginal progesterone capsules

Locations

Country Name City State
Belgium Centrum voor Reproductieve Geneeskunde Jette Brussel

Sponsors (4)

Lead Sponsor Collaborator
CRG UZ Brussel Abbott, KU Leuven, Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Tournaye H, Sukhikh GT, Kahler E, Griesinger G. A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization. Hum Reprod. 2017 May 1;32(5):1019-1027. doi: 10.1093/humrep/dex023. Erratum in: Hum Reprod. 2017 Oct 1;32(10):2152. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Molecular endometrial level using illumina RNA-seq To study the difference of OD versus MVP as LPS after controlled ovarian stimulation (COS) on the molecular endometrial level using Illumina RNA-seq on endometrial derived single cell suspensions On the eight day (at 8am) of LPS intake
Primary Molecular endometrial level using immunohistochemistry To study the difference of OD versus MVP as LPS after controlled ovarian stimulation (COS) on the molecular endometrial level using immunohistochemistry on endometrial derived single cell suspensions On the eight day (at 8am) of LPS intake
Primary Molecular endometrial level using flow cytometry To study the difference of OD versus MVP as LPS after controlled ovarian stimulation (COS) on the molecular endometrial level using flow cytometry on endometrial derived single cell suspensions On the eight day (at 8am) of LPS intake
Secondary Difference in pharmacokinetic profile: Progesterone: AUC0-t using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Secondary Difference in pharmacokinetic profile: Progesterone: AUC0-t using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the first day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose.
Secondary Difference in pharmacokinetic profile: Progesterone: Cmax using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Secondary Difference in pharmacokinetic profile: Progesterone: tmax using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Secondary Difference in pharmacokinetic profile: Progesterone: Ctrough using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the eight day of LPS intake: 1 hour before morning dose.
Secondary Difference in pharmacokinetic profile: Progesterone: ?z using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Secondary Difference in pharmacokinetic profile: Progesterone: t1/2 using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Secondary Difference in pharmacokinetic profile: Progesterone: CL/F using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Secondary Difference in pharmacokinetic profile: Progesterone: Vz/F using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Secondary Difference in pharmacokinetic profile: Dydrogesterone and 20a-dihydrodydrogesterone: AUC0-t using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Secondary Difference in pharmacokinetic profile: Dydrogesterone and 20a-dihydrodydrogesterone: ratios of AUC0-t of dydrogesterone and DHD using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Secondary Difference in pharmacokinetic profile: Dydrogesterone and 20a-dihydrodydrogesterone: AUC0-t using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the first day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose.
Secondary Difference in pharmacokinetic profile: Dydrogesterone and 20a-dihydrodydrogesterone: ratios of AUC0-t of dydrogesterone and DHD using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the first day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose.
Secondary Difference in pharmacokinetic profile: Dydrogesterone and 20a-dihydrodydrogesterone: Cmax using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Secondary Difference in pharmacokinetic profile: Dydrogesterone and 20a-dihydrodydrogesterone: ratios of Cmax of dydrogesterone and DHD using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Secondary Difference in pharmacokinetic profile: Dydrogesterone and 20a-dihydrodydrogesterone: tmax using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Secondary Difference in pharmacokinetic profile: Dydrogesterone and 20a-dihydrodydrogesterone: Ctrough using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the eight day of LPS intake: 1 hour before morning dose.
Secondary Difference in pharmacokinetic profile: Dydrogesterone and 20a-dihydrodydrogesterone: ?z using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Secondary Difference in pharmacokinetic profile: Dydrogesterone and 20a-dihydrodydrogesterone: t1/2 using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Secondary Difference in pharmacokinetic profile: Dydrogesterone and 20a-dihydrodydrogesterone: CL/F using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Secondary Difference in pharmacokinetic profile: Dydrogesterone and 20a-dihydrodydrogesterone: Vz/F using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day.
Secondary Difference in peripheral immunology To study the effects of OD versus MVP on the peripheral immunology (using flow cytometry to investigate T regulatory and T effector cells derived from peripheral blood) On the first and eight day of LPS intake, 1hour before morning dose at 9 am.
Secondary Difference in microbiota in the female genital tract by cervical swab, a vaginal swab (posterior fornix) and an intra-uterine sample using an empty embryo catheter. Evaluation using 16S rRNA amplicon sequencing - Illumina miSeq On the first and eight day of LPS intake, 1 hour before morning dose at 9 am.
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