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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03353883
• Other study ID #: khalid 5
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 21, 2017
• Last updated: November 23, 2017
• Start date: June 1, 2017
• Est. completion date: August 2018

Study information

• Verified date: November 2017
• Source: Benha University
• Contact: Khalid M Salama
• Phone: 01225861026
• Email: dr.khalid_sleem[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:infertile women with impaired ovulation -

Exclusion Criteria:

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

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

Locations

Country	Name	City	State
Egypt	Benha university hospital	Banha	Qaluibia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Azimi Nekoo E, Chamani M, Shahrokh Tehrani E, Hossein Rashidi B, Davari Tanha F, Kalantari V. Artificial Endometrial Preparation for Frozen-Thawed Embryo Transfer with or without Pretreatment with Depot Gonadotropin Releasing Hormone Agonist in Women with — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy outcome	pregnancy test-Transvaginal sonograghy	4 weeks

External Links

•   infertility