Unexplained Infertility Clinical Trial
Official title:
Luteal Phase Support With Progesterone vs Estrogen and Progesterone on Pregnancy Rates in Ovarian Stimulation and Intrauterine Insemination Cycles: a Prospective Randomized Study
This is a single center, 3 arms, prospective randomized controlled open study to determine
the impact of luteal phase support on pregnancy rates in ovarian stimulation and IUI cycles
with recombinant FSH in patients with unexplained infertility and mild male factor.
Patients will be randomized into 3 groups:
1. Luteal support with progesterone only (they will received vaginal P gel (Crinone 8%
vaginal gel; Serono, Israel)
2. Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel)
and Estrofem 4mg].
3. No luteal support
Status | Not yet recruiting |
Enrollment | 400 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 40 Years |
Eligibility |
Inclusion Criteria: 1. Couples with diagnosis of unexplained infertility 2. In their treatment cycle with ovarian stimulation and IUI using recombinant FSH in our institution. Exclusion Criteria: 1. female partners with one or more of the following: - previous ovarian surgery - one ovary - polycystic ovaries on ultrasound examination - other endocrine abnormalities (i.e., polycystic ovarian syndrome, thyroid disorders,hyperprolactinemia,6.hypogonadotropic hypogonadism) - past ovarian hyperstimulation or hyperstimulation during the study period - diminished ovarian reserve (basal FSH level >15 IU/mL) - age of >40 years 2. sever male factor < 5 million total motile sperm on the day of insemination. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Rabin Medical Center | Petach-Tikva |
Lead Sponsor | Collaborator |
---|---|
Rabin Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Pregnancy | A pregnancy test will be performed 2 weeks after insemination (Serum hCG) an intrauterine pregnancy will be confirmed using a transvaginal ultrasound 2 weeks after a positive pregnancy test | 4 weeks after insemintation | No |
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