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

Primary Purpose

Unexplained Infertility, Mild Male Factor

Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Luteal support with progesterone only
Luteal support with estrogen + progesterone
Insemination without luteal support
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unexplained Infertility focused on measuring Unexplained infertility, Insemination, Luteal phase support, Ovarian stimulation

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rabin Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Luteal support with progesterone only

Luteal support with estrogen + progesterone

No luteal support

Arm Description

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.

Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg].

Outcomes

Primary Outcome Measures

Clinical Pregnancy
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

Secondary Outcome Measures

Full Information

First Posted
November 8, 2010
Last Updated
November 8, 2010
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01237535
Brief Title
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

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
November 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel) Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg]. 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: Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel) Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg]. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unexplained Infertility, Mild Male Factor
Keywords
Unexplained infertility, Insemination, Luteal phase support, Ovarian stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Luteal support with progesterone only
Arm Type
Experimental
Arm Description
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.
Arm Title
Luteal support with estrogen + progesterone
Arm Type
Experimental
Arm Description
Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg].
Arm Title
No luteal support
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Luteal support with progesterone only
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Luteal support with estrogen + progesterone
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Insemination without luteal support
Intervention Description
Routine insemination procedure without luteal support
Primary Outcome Measure Information:
Title
Clinical Pregnancy
Description
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
Time Frame
4 weeks after insemintation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Couples with diagnosis of unexplained infertility In their treatment cycle with ovarian stimulation and IUI using recombinant FSH in our institution. Exclusion Criteria: 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 sever male factor < 5 million total motile sperm on the day of insemination.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Galia Oron
Phone
972-3-9377492
Email
orong@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Galia Oron, Dr
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petach-Tikva
ZIP/Postal Code
49202
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Galia Oron, Dr
Phone
972-3-9377492
Email
orong@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Galia Oron, Dr

12. IPD Sharing Statement

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

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