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Completed

NCT Number: NCT05340010

Administration of Human Chorionic Gonadotrophin Before Secretory Transformation of Frozen-thawed Embryo Transfer Cycles

Successful embryo implantation is complicated process that requires synchrony between good-quality embryos and receptive endometrium. Human chorionic gonadotropin (hCG), is one of the initial embryonic signals and the major embryoendometrial relationship regulator. This study will be conducted to to investigate the role of parenteral hCG used for the transfer of cryopreserved- thawed embryos with HRT cycles in the outcome of artificially prepared frozen embryo transfer (FET) cycles.

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Key information

Conditions

hCG FET Frozen-thawed Embryo Transfe Human Chorionic Gonadotrophin

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Alexandria university

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient age ≤ 38 years.
  • Normal 3D transvaginal ultrasound.
  • At least two good quality embryos cryopreserved by vitrification.
  • No GnRH agonists administration before FET cycle.

Exclusion criteria

  • Endometriosis.
  • Uterine anomalies.
  • Evidence of hydrosalpinx by hystrosalpingography or ultrasound.
  • Evidence of immune disease, hematological or hormonal disorder.

Treatment and study plan

Human Chorionic Gonadotrophin Intramuscular injection 10.000 IU

Drug

From the 12th to 13th day of the cycle when endometrium reached the optimal thickness ≥8 mm, group 1 (hCG) will receive 10.000 IU hCG intramuscular injection in the morning then vaginal suppository progesterone 400 mg twice a day will be started in the afternoon

Primary outcomes

  1. Live birth delivery rate (LBR)

    Time frame: 7 months

    Number of live births beyond 28 weeks of gestational age to the total number of FET cycles

Secondary outcomes

  1. Clinical pregnancy rate

    Time frame: 2 weeks after positive pregnancy test

    number of cases with observed gestational sac with embryonic heartbeat detected by ultrasound two weeks after positive pregnancy to the totoal number of frozen embryo transfer cycles.

  2. Implantation rate

    Time frame: 2 weeks after positive pregnancy test

    proportion of the number of gestational sacs to the number of embryos transferred

  3. Miscarriage rate

    Time frame: 20 weeks gestational age

    number of lost before the 20th week of gestation to the number of clinical pregnancies

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2022
Registry last updated
Sep 1, 2022

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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