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Completed

NCT Number: NCT02736032

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini), Cairo, Egypt

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Embryo transfer

Procedure

The transfer of cryopreserved-thawed embryos inside the uterus aiming to achieve pregnancy

Serum Estradiol and Progesterone levels

Procedure

Serum estradiol and serum progesterone levels in blood on the day of start of progesterone supplementation

GnRH agonist

Drug

GnRH agonist given on day 21 of the cycle preceding the embryo transfer

Other names: Decapeptyl SR

External Estradiol

Drug

Estradiol started on day1 of the cycle for endometrial prepartaion

Other names: estradiol valerate of Cycloprogenova tablets

Progesterone

Drug

progesterone as luteal phase support start after endometrium is well prepared

Other names: Cyclogest vaginal suppositories

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 5 weeks after embryo transfer]

    the detection of intrauterine gestational sac with positive pulsations

  2. Live birth rate

    Time frame: 9 months

    Pregnancy ending with a live birth

Secondary outcomes

  1. Estradiol and Progesterone levels on day of start of progesterone supplementation

    Time frame: 12 to 20 days

    The serum levels of estradiol and progesterone before embryo transfer

  2. Endometrial thickness on day of start of progesterone supplementation

    Time frame: 12 to 20 days

    The endometrial thickness on the day of starting progesterone supplementation to transfer the embryos

  3. Number of days needed for adequate (> 8mm) endometrial thickness

    Time frame: 12 to 20 days

    Number of days on external hormones to prepare endometrium

  4. Cycle cancellation: not related to thawing, thin endometrium, high P. OR related to embryos not surviving thawing.

    Time frame: 12 to 20 days

    Cycle cancellation: not related to thawing, thin endometrium, high Progesterone. OR related to embryos not surviving thawing.

  5. Chemical pregnancy rate

    Time frame: 14 days after embryo transfer

    positive serum Beta HCG 14 days after embryo transfer

  6. Implantation rate.

    Time frame: 5 weeks after embryo transfer

    the ratio between the number of embryos transferred and the number of sacs

  7. Early miscarriage rate

    Time frame: 3 months

    Pregnancy loss in the first 12 weeks gestation

  8. Ongoing pregnancy rate

    Time frame: 3 months

    Pregnancy ongoing beyond 12 weeks gestation

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Kamal Shaeer center of infertility
  • Nile Ivf Center, Cairo, Egypt

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 13, 2016
Registry last updated
May 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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