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

This study is not yet open for participant recruitment.
Verified November 2010 by Rabin Medical Center
Sponsor:
Information provided by:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01237535
First received: November 8, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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

Condition Intervention Phase
Unexplained Infertility
Mild Male Factor
 Drug: Luteal support with progesterone only
Drug: Luteal support with estrogen + progesterone
Procedure: Insemination without luteal support
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Clinical Pregnancy [ Time Frame: 4 weeks after insemintation ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 400
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Luteal support with progesterone only
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
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.
Experimental: Luteal support with estrogen + progesterone
Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg].
 Drug: Luteal support with estrogen + progesterone
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.
No Intervention: No luteal support Procedure: Insemination without luteal support
Routine insemination procedure without 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

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01237535

Contacts
Contact: Galia Oron 972-3-9377492 orong@clalit.org.il

Locations
Israel
Rabin Medical Center Not yet recruiting
Petach-Tikva, Israel, 49202
Contact: Galia Oron, Dr     972-3-9377492     orong@clalit.org.il    
Principal Investigator: Galia Oron, Dr            
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Galia Oron, Dr Rabin Medical Center
  More Information

No publications provided

Responsible Party: Dr. Galia Oron, Rabin medical center
ClinicalTrials.gov Identifier: NCT01237535     History of Changes
Other Study ID Numbers: rmc005788ctil
Study First Received: November 8, 2010
Last Updated: November 8, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Unexplained infertility
Insemination
Luteal phase support
Ovarian stimulation

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Estrogens
Progesterone
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Progestins

ClinicalTrials.gov processed this record on May 19, 2013