NCT01237535

Luteal Phase Support With Progesterone Versus Estrogen and Progesterone on Pregnancy Rates

Luteal Phase Support With Progesterone vs Estrogen and Progesterone on Pregnancy Rates in Ovarian Stimulation and Intrauterine Insemination Cycles: a Prospective Randomized Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Unexplained Infertility
• Mild Male Factor

Interventions

Type	Name	Description
DRUG	Luteal support with progesterone only	Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel).Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.
DRUG	Luteal support with estrogen + progesterone	Luteal support with estrogen + progesterone \[(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg\].Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.
PROCEDURE	Insemination without luteal support	Routine insemination procedure without luteal support

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2010-11-09
• Last updated: 2010-11-09

Locations

1 site across 1 country: Israel