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

Study Overview
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Brief Summary
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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: Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel) Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg]. No luteal support

Detailed Description
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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: Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel) Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg]. 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.

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

Conditions
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Unexplained Infertility, Mild Male Factor

Intervention / Treatment
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* Drug: Luteal support with progesterone only
* Drug: Luteal support with estrogen + progesterone
* Procedure: Insemination without luteal support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Couples with diagnosis of unexplained infertility In their treatment cycle with ovarian stimulation and IUI using recombinant FSH in our institution. Exclusion Criteria: 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 sever male factor < 5 million total motile sperm on the day of insemination.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Luteal support with progesterone only<br>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. | Drug: Luteal support with progesterone only<br>* 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.<br>|
| Experimental: Luteal support with estrogen + progesterone<br>Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg]. | Drug: Luteal support with estrogen + progesterone<br>* 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.<br>|
| No Intervention: No luteal support<br> | Procedure: Insemination without luteal support<br>* Routine insemination procedure without luteal support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Unexplained infertility, Insemination, Luteal phase support, Ovarian stimulation