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
Study design:
single center, 3 arms, prospective randomized controlled open study
Objective:
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.
Methods:
All patients in all study groups will undergo a single insemination procedure and then 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
Luteal support will begin after insemination and will be continued through the 12th week of
gestation if the patient conceived. 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. If no pregnancy will be achieved
patients will undergo 3 treatment cycles preferably in the same treatment group.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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