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Subcutaneous vs Vaginal Progesterone for Luteal Phase Support in IVF
NCT00827983Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2009
- Primary completion
- Nov 2010
- Countries
- 5
- Sponsor
- IBSA Group
- Modality
- Small Molecules
- Drugs
- progesterone
- Conditions
- infertility
01
Overview
Phase 3, randomised, open-label trial of progesterone in infertility (2 arms), sponsored by IBSA Group. Primary endpoint: Ongoing Pregnancy Rate at the End of the Study at 10 weeks. Started Jan 2009; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Progesterone SC
Progesterone 25 mg s.c. once daily
Progesterone Vaginal gel
Progesterone 90 mg vaginally once daily
03
Who it enrols
Women aged 18-42 undergoing IVF with BMI <30, <3 prior ART cycles, and normal uterine cavity. Excludes severe endometriosis, hydrosalpinx, and uterine fibroids distorting the cavity.
04
Endpoints
Primary
Ongoing Pregnancy Rate at the End of the Study
Secondary
Delivery Rate
Live Birth Rate
Implantation Rate
05
Results
Primary endpoints met
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