A Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization

Female Infertility Clinical Trial

— Lotus I  

Official title:

A Double-Blind, Double-Dummy, Randomized, Two-arm, Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Intravaginal Micronized Progesterone Capsules 600 mg Daily for Luteal Support in In-Vitro Fertilization (Lotus I)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850030
• Other study ID #: M13-563
• Secondary ID: 2012-002215-26
• Status: Completed
• Phase: Phase 3
• First received: April 19, 2013
• Last updated: May 31, 2017
• Start date: August 2013
• Est. completion date: March 2016

Study information

• Verified date: May 2017
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Female inability to conceive a child. The purpose of this randomized, two-arm and double blind, double dummy study is to demonstrate that the treatment of a daily dose of 3x10mg dydrogesterone orally is as effective and safe as the daily dose of 3x200 mg micronized progesterone capsules administered intravaginally for the luteal support in patients undergoing IVF. The treatment will start on the day of oocyte retrieval and continue until pregnancy is negative or until week 12 gestation.Patients will be followed after treatment until 30 days after delivery to record any safety and tolerability data of the patient and their newborn(s).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1070
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 41 Years

Eligibility

Inclusion Criteria:

• Signed informed consent

• Premenopausal females, age > 18 years < 42 years

• Non-smokers. For females who were past smokers, they must have stopped tobacco usage for at least 3 months prior baseline visit

• Early follicular phase (Day 2-4) Follicle stimulating hormone (FSH) less than or equal to 15 IU/L and estradiol (E2)within normal limits

• Luteinizing hormone (LH), prolactin (PRL), T (testosterone) and thyroid-stimulating hormone (TSH), within the normal limits for the clinical laboratory, or considered not clinically significant by the Investigator within 6 months prior to screening

• Documented history of infertility (e.g., unable to conceive for at least one year or for 6 months for women = 38 years of age or bilateral tubal occlusion or absence)

• Normal transvaginal ultrasound at screening (or within 14 days of screening) without evidence of clinically significant abnormality consistent with finding adequate for Assisted Reproductive Technology (ART) with respect to uterus and adnexa (no hydrosalpinx or clinically relevant uterine fibroids)

• Negative pregnancy test on the day of pituitary down regulation (prior to administration of gonadotropin releasing hormones (GnRH) agonist or GnRH antagonist)

• Clinically indicated protocol for induction of IVF with a fresh embryo

• Single or dual embryo transfer

• BMI = 18 and = 30 kg/m2

Exclusion Criteria:

• Evidence of cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, head, ears, eyes, nose, throat (HEENT), 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

• Known allergic reactions to progesterone products

• Known allergic reactions to peanuts and peanut oil

• Intake of experimental drug or 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 to participate in or to complete the study

• Current or recent substance abuse, including alcohol and tobacco (Note: Patients who stopped tobacco usage at least 3 months prior to screening visit would be allowed)

• History of chemotherapy or radiotherapy

• Patients with more than 3 unsuccessful IVF attempts

• Contraindication for pregnancy

• Refusal or inability to comply with the requirements of the study protocol for any reason, including scheduled clinic visits and laboratory tests

• History of recurrent pregnancy loss defined as 3 or more spontaneous miscarriages

Related Conditions & MeSH terms

• Female Infertility
• Infertility
• Infertility, Female

Intervention

Drug:
• Dydrogesterone 30 mg
Oral Dydrogesterone 10 mg tablets tid
• Micronized Progesterone 600 mg
Intravaginal micronized progesterone 200 mg capsules tid
• Placebo progesterone
Placebo intravaginal micronized progesterone 200 mg capsules tid
• Placebo dydrogesterone
placebo oral dydrogesterone 10 mg tablets tid

Locations

Country	Name	City	State
Austria	Site reference no. 113176	Vienna
Belgium	Site reference no. 93593	Brasschaat
Belgium	Site reference no. 93598	Brussels
Belgium	Site reference no. 93615	Brussels
Belgium	Site reference no. 93617	Brussels
Belgium	Site reference no. 93613	Genk
Belgium	Site reference no. 93594	Gent
Belgium	Site reference no. 93597	Gent
Belgium	Site reference no. 93616	Hasselt
Belgium	Site reference no. 93595	Leuven
Belgium	Site reference no. 93614	Mons
Finland	Site reference ID ORG-000884	Helsinki
Finland	Site reference ID ORG-000885	Jyväskylä
Finland	Site reference no. ORG-000635	Oulu
Finland	Site reference ID ORG-000795	Tampere
Finland	Site reference no. ORG-000633	Turku
Germany	Site reference ID ORG-000643	Berlin
Germany	Site reference ID ORG-000645	Berlin
Germany	Site reference ID ORG-000642	Dresden
Germany	Site reference ID ORG-000644	Heidelberg
Germany	Site reference ID ORG-000883	Luebeck
Israel	Site reference no. 93635	Be'er Sheva
Israel	Research facility ID ORG-000934	Hadera
Israel	Research facility ID ORG-000935	Haifa
Israel	Site reference no. 93638	Jerusalem
Israel	Site reference no. 93641	Tel Aviv
Russian Federation	Center of Family Medicine LC	Ekaterinburg
Russian Federation	FSBI "Ural SRI of Maternity and Child Protection" of MoH and SD	Ekaterinburg
Russian Federation	CJSC "Nasledniki"	Moscow
Russian Federation	FGBU Endocrinology Research Center of Minzdrav of Russia	Moscow
Russian Federation	Moscow State Medical Dentistry University	Moscow
Russian Federation	Moscow State Medical Dentistry University	Moscow
Russian Federation	SBEIHPE - NWSMU n.a.l.l.Melnichko MoH and SD of RF	St. Petersburg
Russian Federation	St. Petersburg SBHI "Maternity Hospital No 17" (main address)	St. Petersburg
Spain	Site reference no. 119915	Baracaldo, Vizcaya
Spain	Site reference ID ORG-000791	Barcelona
Spain	Site reference no. ORG-000639	Bilbao
Spain	Site reference no. ORG-000640	Pozuelo de Alarcon (Madrid)
Spain	Site reference no. ORG-000638	Sevilla
Spain	Site reference no. ORG-000637	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Quintiles, Inc.

Countries where clinical trial is conducted

Austria,  Belgium,  Finland,  Germany,  Israel,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Being Pregnant as Measured by the Presence of Fetal Heart Beats at 12 Weeks´Gestation Using Transvaginal Ultrasound	Percentage of participants being pregnant as measured by the presence of fetal heart beats at 12 weeks´gestation using transvaginal ultrasound	12 weeks´ gestation (at visit 6)
Secondary	Percentage of Participants Being Pregnant as Measured by the Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer	Percentage of participants being pregnant as measured by the positive biochemical pregnancy test on Day 14 after embryo transfer	Day 14 after embryo transfer
Secondary	Percentage of Participants With a Successful Completion of Pregnancy	Incidence of live births and healthy newborns	After delivery (about 9 months after IVF)
Secondary	Gender of the Newborn	was recorded and collected for Newborn	After delivery (about 9 months after IVF)