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

NCT03353883 | Unknown Phase 2 DMC

• 1 other identifier: khalid 5
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

• pregnancy outcome

  pregnancy test-Transvaginal sonograghy

  4 weeks

Study Arms (2)

(Group A) Midluteal Triptorelin depot

ACTIVE COMPARATOR

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

(Group B)first day Triptorelin depot

ACTIVE COMPARATOR

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

Interventions

Triptorelin SR DRUG

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

Also known as: Decapeptyl

(Group A) Midluteal Triptorelin depot; (Group B)first day Triptorelin depot

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha university hospital

Banhā, Qaluibia, Egypt

RECRUITING

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

  PMID: 25904960 RESULT

Related Links

• infertility

MeSH Terms

Conditions

Infertility, Female

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Khalid M Salama, MD

  Associate professor of obestetric and gynecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khalid M Salama

CONTACT

01225861026; dr.khalid_sleem@yahoo.com

Hesham M Abo Ragab

CONTACT

01002599027; ahmed-1919@windowslive.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: sealed envelopes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistent professor

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 27, 2017
• Study Start: June 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: August 1, 2018
• Last Updated: November 27, 2017

Record last verified: 2017-11

Locations

EG (1)