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

Information source: Rabin Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Unexplained Infertility; Mild Male Factor

Intervention: Luteal support with progesterone only (Drug); Luteal support with estrogen + progesterone (Drug); Insemination without luteal support (Procedure)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Rabin Medical Center

Official(s) and/or principal investigator(s):
Galia Oron, Dr, Principal Investigator, Affiliation: Rabin Medical Center

Overall contact:
Galia Oron, Phone: 972-3-9377492, Email: orong@clalit.org.il

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Clinical Pregnancy

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

Minimum age: 20 Years. Maximum age: 40 Years. Gender(s): Both.

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.

Locations and Contacts

Galia Oron, Phone: 972-3-9377492, Email: orong@clalit.org.il

Rabin Medical Center, Petach-Tikva 49202, Israel; Not yet recruiting
Galia Oron, Dr, Phone: 972-3-9377492, Email: orong@clalit.org.il
Galia Oron, Dr, Principal Investigator
Additional Information

Starting date: November 2011
Last updated: November 8, 2010

Page last updated: August 23, 2015

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