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OpenTrials
Completed

NCT Number: NCT03581422

Natural Cycles With Spontaneous Versus Induced Ovulation in FET

In recent years, frozen-thawed embryo transfer procedure (FET) has been widely used to increase the cumulative pregnancy rate per IVF-cycle: which is the best preparation protocol remains a matter of debate.

A retrospective analysis was conducted between 2012-2017. The aim was comparing clinical pregnancy rate (CPR) of pure natural cycle frozen-thawed embryo transfer (NC-FET) versus natural cycle frozen-thawed embryo transfer with hCG-triggered ovulation (mNC-FET).

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

About this study

Compared to repeated oocyte retrieval procedure, frozen-thawed embryo transfer (FET) has been widely used to increase the cumulative pregnancy rate per IVF-cycle, with demonstrated superiority in preventing ovarian hyperstimulation syndrome and improving cost-efficiency and time to pregnancy.

It is controversial whether triggering ovulation of the dominant follicle using human chorionic gonadotrophin (hCG) may benefit or reduce embryo implantation, when compared with a natural cycle environment. Unfavourable clinical outcomes of controlled ovarian stimulation have been reported by recently published studies, compared to the spontaneous LH surge.

This study aimed to compare the effectiveness in terms of better clinical pregnancy rates (CPR) of pure natural cycle frozen-thawed embryo transfer (NC-FET) versus natural cycle frozen-thawed embryo transfer modified by HCG administration\\with hCG-triggered ovulation (mNC-FET).

A retrospective analysis was conducted between 2012-2017. In patients with regular ovulatory cycles, the timing of embryo thawing and transferring was based on spontaneous LH surge (NC-FET). Patients attended for ultrasound evaluation of the dominant follicle from Day 8 to 10 of their menstrual cycle (depending on cycle length), detecting luteinizing hormone (LH) surge in urine/ taking an ovulation test for urinary LH measurement. In selected cases, a serum assays of LH, progesterone and estradioI has been further obtained. When the endometrial thickness reached 8 mm and dominant follicle 16-20 mm in diameter, hCG was administered in absence of urinary LH surge. Embryo thawing and transfer was planned 7 days after LH surge or HCG administration, whether G5 or G6 blastocyst. Exogenous progesterone supplementation started 2 days after hCG administration versus the same day of embryo transfer procedure in NC- ET. To limit potential confounders, only single blastocyst transfer cycles were included, vitrified on Days 5 or 6, excluding PGT-a (Pre Gestational Test for aneuploydia) cycles and cleavage stage embryo transfers. A unilevel and multi level logistic regression analysis was conducted using Stata Software versione15.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • only single blastocyst transfer cycles were included

Exclusion criteria

  • PGT-a cycles and cleavage stage embryo transfers

Treatment and study plan

hCG administration before embryo transfer

Drug

Thawed embryo transfer with ovulation triggered by hCG

Other names: Gonasi HP 5000 UI or Ovitrelle 250mg

Primary outcomes

  1. CPR in NCFET vs mNCFET

    Time frame: 2012-2017

    compare the effectiveness in terms of better clinical pregnancy rates (CPR) of pure natural cycle frozen-thawed embryo transfer (NC-FET) versus natural cycle frozen-thawed embryo transfer modified by HCG administration

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

Frozen-Thawed Embryo Transfers: a Comparison Between Natural Cycles With Spontaneous or Induced Ovulation

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
Jul 10, 2018
Registry last updated
Jul 19, 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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