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

NCT ID: NCT03353883

Last Updated: 2017-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
sealed envelopes

Study Groups

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(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.

Group Type ACTIVE_COMPARATOR

Triptorelin SR

Intervention Type DRUG

GnRH agonist depot( Decapeptyl) will be taken in the previous mid luteal cycle in group A and the first day in group B

(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.

Group Type ACTIVE_COMPARATOR

Triptorelin SR

Intervention Type DRUG

GnRH agonist depot( Decapeptyl) will be taken in the previous mid luteal cycle in group A and the first day in group B

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Decapeptyl

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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khalid mohammed salama

assistent professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Khalid M Salama, MD

Role: PRINCIPAL_INVESTIGATOR

Associate professor of obestetric and gynecology

Locations

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Benha university hospital

Banhā, Qaluibia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Khalid M Salama

Role: CONTACT

Phone: 01225861026

Email: [email protected]

Hesham M Abo Ragab

Role: CONTACT

Phone: 01002599027

Email: [email protected]

Facility Contacts

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khalid M salama, MD

Role: primary

khalid M salama, MD

Role: backup

References

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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 Regular Menses. J Family Reprod Health. 2015 Mar;9(1):1-4.

Reference Type RESULT
PMID: 25904960 (View on PubMed)

Related Links

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http://bu.edu.eg

infertility

Other Identifiers

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khalid 5

Identifier Type: -

Identifier Source: org_study_id