Dydrogesterone versus micronized vaginal progesterone (MVP) for luteal phase support (LPS) in hormone replacement therapy (HRT) frozen embryo transfer (FET) cycles. - REMODE

Phase 1

• Conditions: progesterone as luteal phase supplementation in frozen embryo transfer cycles; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2020-004491-17-BE
• Lead Sponsor: Z Brussel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-28
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

•=40 years of age at the time of IVF/ICSI treatment
•BMI =18 to =30 kg/m2 with a documented history of infertility
•Have undergone COS as part of an ART treatment and have had an unsuccessful fresh embryo transfer in that cycle, OR, have undergone freeze all strategy
•Scheduled to undergo FET with a standard exogenous/programmed hormonal replacement therapy (HRT) regimen
•Have at least 1 blastocyst vitrified on the 5th or 6th day after oocyte retrieval
•Elective single embryo (blastocyst) transfer (SET)
•Normal ultrasound examination at enrollment (or if <12 months old)
•Signed patient authorization for use/disclosure of data.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Women with a history of recurrent miscarriage, defined as >2 consecutive miscarriages (biochemical pregnancy losses are not included)
•Absence of implantation (serum hCG = negative) after two consecutive cycles of IVF, ICSI or FET where the cumulative number of transferred embryos was >4 cleavage-stage embryos and >2 blastocysts
•Presence of hydrosalpinx that is not surgically treated
•Endometrial abnormalities on scanning during ovarian stimulation, such as endometrial polyp(s), sub mucosal fibroid(s), endometrial hyperplasia, endometrial fluid accumulation, or endometrial adhesions
•Participating in another clinical study at the same time
•Known allergic reactions to dydrogesterone or other progestogens products
•Any contraindication or other condition that precludes use of dydrogesterone in a particular patient, in accordance with the precautions listed in the locally approved label
•Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subjects in or to complete the study
•History of prior chemotherapy
•Contraindication for pregnancy
•Transfer of >1 embryo

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified