Infertility Clinical Trial
Official title:
Impact of Luteal Phase Support With Vaginal Progesterone on the Clinical Pregnancy Rate in Intrauterine Insemination Cycles Stimulated With Gonadotrophins: a Prospective Randomized Multicentre Study.
NCT number | NCT01826747 |
Other study ID # | S52775 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | April 2011 |
Est. completion date | June 2016 |
Verified date | October 2018 |
Source | Universitaire Ziekenhuizen Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective is to test the hypothesis that luteal phase support with vaginal progesterone leads to a higher clinical pregnancy rate (primary outcome) and live birth rate (secondary outcome) when compared to no luteal phase support in a program of intrauterine insemination (IUI) after controlled ovarian stimulation with gonadotrophins. Additionally, the length of the luteal phase will be recorded (secondary outcome) in order to detect luteal phase defects/insufficiencies in the absence of luteal phase suppletion as well as luteal phase prolongation in case of luteal phase support which may be a burden for the patients waiting for the outcome of the treatment.
Status | Completed |
Enrollment | 393 |
Est. completion date | June 2016 |
Est. primary completion date | January 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 43 Years |
Eligibility |
Inclusion Criteria: Patients with an indication for IUI: - unexplained infertility - mild male factor infertility - minimal-mild endometriosis Women: - first IUI cycle ever - normal ovulatory cycles (26-32d) - age<43,BMI=30 - presence of at least one patent tube on hysterosalpingography and/or laparoscopy - normal uterine cavity (ultrasound, hysterosalpingography, or laparoscopy) Men: Total motile count = 5 Million/ml after capacitation Exclusion Criteria: - Patients with contra-indication for pregnancy , infertility or progesterone use. |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | clinical pregnancy rate per IUI cycle | by ultrasound at ± 5 to 6 weeks after IUI | ||
Secondary | live birth rate per IUI cycle | 40 weeks after IUI |
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