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

Clalit Health Services

Status and phase: Unknown; Phase 4

Conditions: Unexplained Infertility; Mild Male Factor

Treatments: Procedure: Insemination without luteal support; Drug: Luteal support with estrogen + progesterone; Drug: Luteal support with progesterone only

Study type: Interventional

Funder types: Other

Identifiers

NCT01237535

rmc005788ctil

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 3 patient groups

Luteal support with progesterone only

Experimental group

Description:

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.

Treatment:

Drug: Luteal support with progesterone only

Luteal support with estrogen + progesterone

Experimental group

Description:

Luteal support with estrogen + progesterone \[(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg\].

Treatment:

Drug: Luteal support with estrogen + progesterone

No luteal support

No Intervention group

Treatment:

Procedure: Insemination without luteal support