Cryopreserved-thawed Embryo Transfer With or Without Gonadotropin Releasing Hormone Agonist

Infertility Clinical Trial

Official title:

Cryopreserved-thawed Embryo Transfer in Down or Non-down Regulated Hormonally Controlled Cycles: a Prospective, Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02736032
• Other study ID #: 12016
• Status: Completed
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: May 2018

Study information

• Verified date: May 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Traditionally, the use of GnRH-a suppression was considered essential for adequate endometrial hormonal modulation in cryopreserved-thawed embryo transfer cycles. Several studies, however, have questioned its necessity for controlled endometrial preparation. Using a high dose of estradiol from day 1 of the cycle will suppress the gonadotroph, preventing folliculogenesis and excessive secretion of LH, allowing adequate endometrial preparation without GnRH-a.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• 20-35 years

• BMI 20-30

• Regular menses.

• No PCOS, no endometriosis

• No uterine anomalies or lesions

• No severe male factor

• All grade 1 cleaved stage embryos

Exclusion Criteria:

• Less than 20 or more than 35 years

• BMI less than 20 or more than 30

• Irregular cycles

• PCOS or endometriosis

• Uterine anomalies or lesions

• Severe male factor

• Poor quality embryos for transfer

• Severe

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Embryo transfer
The transfer of cryopreserved-thawed embryos inside the uterus aiming to achieve pregnancy
• Serum Estradiol and Progesterone levels
Serum estradiol and serum progesterone levels in blood on the day of start of progesterone supplementation

Drug:
• GnRH agonist
GnRH agonist given on day 21 of the cycle preceding the embryo transfer
• External Estradiol
Estradiol started on day1 of the cycle for endometrial prepartaion
• Progesterone
progesterone as luteal phase support start after endometrium is well prepared

Locations

Country	Name	City	State
Egypt	IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)	Cairo
Egypt	Kamal Shaeer center of infertility	Giza
Egypt	Nile IVF center	Giza

Sponsors (3)

Lead Sponsor	Collaborator
Cairo University	Kamal Shaeer center of infertility, Nile Ivf Center, Cairo, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	the detection of intrauterine gestational sac with positive pulsations	5 weeks after embryo transfer]
Primary	Live birth rate	Pregnancy ending with a live birth	9 months
Secondary	Estradiol and Progesterone levels on day of start of progesterone supplementation	The serum levels of estradiol and progesterone before embryo transfer	12 to 20 days
Secondary	Endometrial thickness on day of start of progesterone supplementation	The endometrial thickness on the day of starting progesterone supplementation to transfer the embryos	12 to 20 days
Secondary	Number of days needed for adequate (> 8mm) endometrial thickness	Number of days on external hormones to prepare endometrium	12 to 20 days
Secondary	Cycle cancellation: not related to thawing, thin endometrium, high P. OR related to embryos not surviving thawing.	Cycle cancellation: not related to thawing, thin endometrium, high Progesterone. OR related to embryos not surviving thawing.	12 to 20 days
Secondary	Chemical pregnancy rate	positive serum Beta HCG 14 days after embryo transfer	14 days after embryo transfer
Secondary	Implantation rate.	the ratio between the number of embryos transferred and the number of sacs	5 weeks after embryo transfer
Secondary	Early miscarriage rate	Pregnancy loss in the first 12 weeks gestation	3 months
Secondary	Ongoing pregnancy rate	Pregnancy ongoing beyond 12 weeks gestation	3 months