Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2025-12-24 @ 10:08 PM
NCT ID:
NCT01237535
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:
NCT01237535
Study Brief:
Protocol Section:
NCT01237535