Clinical trial NCT01237535: Luteal Phase Support With Progesterone Versus Estrogen and Progesterone on Pregnancy Rates
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Unexplained Infertility
Mild Male Factor
Keywords: Unexplained infertility
Insemination
Luteal phase support
Ovarian stimulation
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2010-11-09
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Pregnancy
timeFrame: 4 weeks after insemintation
Secondary outcomes:
Other outcomes:
Locations:
city: Petach-Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Galia Oron, Dr
role: PRINCIPAL_INVESTIGATOR
References: