Status:
COMPLETED
Oral Versus Vaginal Progesterone for Luteal Phase Supplementation in Frozen Embryo Transfer Cycles
Lead Sponsor:
CRG UZ Brussel
Conditions:
Frozen Embryo Transfer
Hormone Replacement Therapy
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief Summary
To investigate the efficacy of dydrogesterone 30 mg compared to micronized vaginal progesterone 800 mg daily for luteal phase support in hormone replacement therapy frozen embryo transfer cycles, as c...
Detailed Description
A randomized controlled trial comparing dydrogesterone 30 mg versus micronized vaginal progesterone 800 mg daily for luteal phase support in hormone replacement therapy frozen embryo transfer cycles. ...
Eligibility Criteria
Inclusion
- ≤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.
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04758871
Start Date
October 1 2021
End Date
June 13 2024
Last Update
June 14 2024
Active Locations (1)
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1
Brussels IVF
Brussels, Belgium, 1090