Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Rabin Medical Center.
Recruitment status was  Not yet recruiting
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

November 8, 2010
November 8, 2010
November 2011
November 2013   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Luteal Phase Support With Progesterone Versus Estrogen and Progesterone on Pregnancy Rates
Luteal Phase Support With Progesterone vs Estrogen and Progesterone on Pregnancy Rates in Ovarian Stimulation and Intrauterine Insemination Cycles: a Prospective Randomized Study

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Unexplained Infertility
  • Mild Male Factor
  • 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.
  • 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.
  • Procedure: Insemination without luteal support
    Routine insemination procedure without luteal support
  • 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.
    Intervention: Drug: Luteal support with progesterone only
  • Experimental: Luteal support with estrogen + progesterone
    Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg].
    Intervention: Drug: Luteal support with estrogen + progesterone
  • No Intervention: No luteal support
    Intervention: Procedure: Insemination without luteal support
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
400
November 2013
November 2013   (final data collection date for primary outcome measure)

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.
Both
20 Years to 40 Years
No
Contact: Galia Oron 972-3-9377492 orong@clalit.org.il
Israel
 
NCT01237535
rmc005788ctil
No
Dr. Galia Oron, Rabin medical center
Rabin Medical Center
Not Provided
Principal Investigator: Galia Oron, Dr Rabin Medical Center
Rabin Medical Center
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP