Infertility Clinical Trial
Official title:
Oral Dydrogesterone Versus Micronized Vaginal Progesterone for Luteal Phase Support in In Vitro Fertilisation (IVF)/ IntraCytoplasmic Sperm Injection (ICSI): Pharmacokinetics and the Impact on the Endometrium, the Microbiota of the Genital Tract and the Peripheral Immunology. Double Blind Crossover Study.
Verified date | December 2020 |
Source | CRG UZ Brussel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Centrum voor Reproductieve Geneeskunde | Jette | Brussel |
Lead Sponsor | Collaborator |
---|---|
CRG UZ Brussel | Abbott, KU Leuven, Universitätsklinikum Hamburg-Eppendorf |
Belgium,
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
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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