Natural Cycles With Spontaneous Versus Induced Ovulation in FET

NCT ID: NCT03581422

Last Updated: 2018-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2866 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2017-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Embryo Transfer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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NC-FET

pure natural cycle frozen-thawed embryo transfer

No interventions assigned to this group

mNC-FET

modified natural cycle frozen-thawed embryo transfer by hCG administration

hCG administration before embryo transfer

Intervention Type DRUG

Thawed embryo transfer with ovulation triggered by hCG

Interventions

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hCG administration before embryo transfer

Thawed embryo transfer with ovulation triggered by hCG

Intervention Type DRUG

Other Intervention Names

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Gonasi HP 5000 UI or Ovitrelle 250mg

Eligibility Criteria

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Inclusion Criteria

* only single blastocyst transfer cycles were included

Exclusion Criteria

* PGT-a cycles and cleavage stage embryo transfers
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Levi Setti PE, Cirillo F, De Cesare R, Morenghi E, Canevisio V, Ronchetti C, Baggiani A, Smeraldi A, Albani E, Patrizio P. Seven Years of Vitrified Blastocyst Transfers: Comparison of 3 Preparation Protocols at a Single ART Center. Front Endocrinol (Lausanne). 2020 May 29;11:346. doi: 10.3389/fendo.2020.00346. eCollection 2020.

Reference Type DERIVED
PMID: 32547496 (View on PubMed)

Other Identifiers

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xxxx2018

Identifier Type: -

Identifier Source: org_study_id

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