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

Phase 4

• Conditions: Unexplained Infertility; Mild Male Factor
• Interventions: Drug: Luteal support with progesterone only; Drug: Luteal support with estrogen + progesterone; Procedure: Insemination without luteal support

• Registration Number: NCT01237535
• Lead Sponsor: Rabin Medical Center

Brief 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.

Study Timeline

• Status Verified: 2010-11
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-08
• Last Update Submitted: 2010-11-08
• Study First Posted: 2010-11-09
• Last Update Posted: 2010-11-09
• Study Start: 2011-11
• Primary Completion: 2013-11
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Luteal support with progesterone only	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.
Luteal support with estrogen + progesterone	Luteal support with estrogen + progesterone	Luteal support with estrogen + progesterone \[(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg\].
No luteal support	Insemination without luteal support	-

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy	4 weeks after insemintation	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

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petach-Tikva, Israel