Early Preparation With Gonadotropin- Releasing Hormon (GnRh) Agonists Injection With Frozen-Thawed Embryo Transfer?

November 23, 2017 updated by: khalid mohammed salama, Benha University

Is Early Preparation With GnRh Agonists Injection on D-1 of Menses of Hormonal Replacement Cycle Improves Pregnancy Rate in Women With Impaired Ovulation and Undergoing Frozen-Thawed Embryo Transfer? A Randomized Controlled Study

The study intended to include >200 infertile women with impaired ovulation who will be subjected to HRT at D-21 of previous menstrual cycle (Group A) or D-1 of menses of replacement cycle (Group B). All patients received the same luteal support in the form of intravaginal progesterone two day before embryos transfer until blood pregnancy test was performed 14 days later. Clinical pregnancy was diagnosed by measurement of β-human chorionic gonadotropin level and was confirmed 2-weeks later by TVU.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study intended to include >200 infertile women with impaired ovulation who will be subjected to HRT at D-21 of previous menstrual cycle (Group A) or D-1 of menses of replacement cycle (Group B). All patients received the same luteal support in the form of intravaginal progesterone two day before embryos transfer until blood pregnancy test was performed 14 days later. The classic Testart slow freezing and rapid thawing protocol was applied on stage-2 pronuclear embryos. Endometrial thickness was measured in the midsagittal plane using transvaginal ultrasound (TVU). Clinical pregnancy was diagnosed by measurement of β-human chorionic gonadotropin level and was confirmed 2-weeks later by TVU.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Qaluibia
      • Banhā, Qaluibia, Egypt
        • Recruiting
        • Benha University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:infertile women with impaired ovulation -

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: (Group A) Midluteal Triptorelin depot
infertile women with impaired ovulation who will be subjected to Triptorelin sustained release(Decapeptyl depot 375 mg one injection )at D-21 of previous menstrual cycle Hormon Replacement Therapy (HRT)Cyclo-Progynova (estradiol, norgestrel)(Group A). All patients received the same luteal support in the form of intravaginal progesterone two day before embryos transfer until blood pregnancy test was performed 14 days later. The classic Testart slow freezing and rapid thawing protocol was applied on stage-2 PN embryos. Endometrial thickness was measured in the midsagittal plane using transvaginal ultrasound (TVU). Clinical pregnancy was diagnosed by measurement of β-HCG level and was confirmed 2-weeks later by TVU.
Drug: Triptorelin SR
GnRH agonist depot( Decapeptyl) will be taken in the previous mid luteal cycle in group A and the first day in group B
Other Names:
  • Decapeptyl
Active Comparator: (Group B)first day Triptorelin depot
infertile women with impaired ovulation who will be subjected toTriptorelin sustained release(Decapeptyl depot 375 mg one injection) at D-1 of menses then Cyclo-Progynova (estradiol, norgestrel) (Group B). All patients received the same luteal support in the form of intravaginal progesterone two day before embryos transfer until blood pregnancy test was performed 14 days later. The classic Testart slow freezing and rapid thawing protocol was applied on stage-2 PN embryos. Endometrial thickness was measured in the midsagittal plane using transvaginal ultrasound (TVU). Clinical pregnancy was diagnosed by measurement of β-Human Chorionic Gonadotropin level and was confirmed 2-weeks later by TVU.
Drug: Triptorelin SR
GnRH agonist depot( Decapeptyl) will be taken in the previous mid luteal cycle in group A and the first day in group B
Other Names:
  • Decapeptyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pregnancy outcome
Time Frame: 4 weeks
pregnancy test-Transvaginal sonograghy
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Principal Investigator: Khalid M Salama, MD, Associate professor of obestetric and gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

November 21, 2017

First Submitted That Met QC Criteria

November 23, 2017

First Posted (Actual)

November 27, 2017

Study Record Updates

Last Update Posted (Actual)

November 27, 2017

Last Update Submitted That Met QC Criteria

November 23, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • khalid 5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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