Deferred Versus Fresh Embryo Transfers

NCT03349905 | Completed

• 2 other identifiers: K160918JAOM160313
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

Brief Summary

Controlled ovarian stimulation (COS) enhances the efficacy of ART (Assisted reproductive technology) by permitting multiple-oocyte yields, but also alters endometrial receptivity (ER) by an advancement of endometrial development which contributes to diminished pregnancy chances. Previous reports suggest that pregnancy rates are increased following deferred frozen embryo transfers. In addition as compared to fresh embryo transfers, frozen embryo transfers seem to be associated with less affected perinatal outcomes, in particular lower risk of preterm birth, small for gestational age and caesarean section. Unfortunately, most of the current evidence is based only on preliminary reports, needing further scientific evidence. Thus, whether differing embryo transfers could restore optimal ER leading to higher live birth rate (LBR) and better obstetrical outcomes as compared to fresh embryo transfers, is actually still under investigation.

Conditions

Infertility, Female

Keywords

Freeze all; IVF; deferred embryo transfer; endometriosis

Outcome Measures

Primary Outcomes (1)

• Live birth rates

  The cut-off of 35 weeks postmenstrual age is to ensure the health and well being of the newborns babies.

  ≥ 35 weeks of gestation after the first single blastocyst embryo transfer according to fresh or deferred-frozen transfer.

Secondary Outcomes (19)

• Miscarriage

  ≥ 35 weeks of gestation after the first single blastocyst embryo transfer a

• Preterm birth

  ≥ 35 weeks of gestation after the first single blastocyst embryo transfer a

• Preterm rupture of membranes

  ≥ 35 weeks of gestation after the first single blastocyst embryo transfer a

• Pre-eclampsia

  ≥ 35 weeks of gestation after the first single blastocyst embryo transfer a

• Placenta praevia

  ≥ 35 weeks of gestation after the first single blastocyst embryo transfer a

Study Arms (2)

Fresh transfer

ACTIVE COMPARATOR

Women randomized in the non experimental group will have: * Antagonist stimulation protocol * Ovarian triggering using a single injection of rhCG (Ovitrelle®; Serono, France) * All of their embryo kept in prolonged culture * A fresh single embryo transfer at blastocyst stage (on day 5 or 6 according to blastocyst stage) * Supernumerary blastocysts cryopreserved

Procedure: fresh transfer

Deferred-frozen embryo transfer

EXPERIMENTAL

Women randomized in the experimental group will have: * Antagonist stimulation protocol * Ovarian triggering using a single injection of 0.2 mg of GnRH agonist triptorelin (Decapeptyl® Ipsen France) * All of their embryo cryopreserved at the blastocyst stage after prolonged embryo culture. * A frozen-thawed single embryo transfer at blastocyst stage, is planned 3-11 weeks after cryopreservation

Procedure: Deferred-frozen embryo transfer

Interventions

fresh transfer PROCEDURE

Women randomized in the non experimental group will have: * Antagonist stimulation protocol * Ovarian triggering using a single injection of rhCG (Ovitrelle®; Serono, France) * All of their embryo kept in prolonged culture * A fresh single embryo transfer at blastocyst stage (on day 5 or 6 according to blastocyst stage) * Supernumerary blastocysts cryopreserved

Fresh transfer

Deferred-frozen embryo transfer PROCEDURE

Women randomized in the experimental group will have: * Antagonist stimulation protocol * Ovarian triggering using a single injection of 0.2 mg of GnRH agonist triptorelin (Decapeptyl® Ipsen France) * All of their embryo cryopreserved at the blastocyst stage after prolonged embryo culture. * A frozen-thawed single embryo transfer at blastocyst stage, is planned 3-11 weeks after cryopreservation

Deferred-frozen embryo transfer

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women \[18 - 40\[years of age (according to date of birth at time of informed consent) who are eligible for ovarian stimulation and ART treatment, including intracytoplasmic sperm injection (ICSI)
• Absence of anatomical abnormalities of the reproductive tract that would interfere with implantation or pregnancy
• Absence of any medical condition in which pregnancy is contraindicated
• Motile, ejaculatory sperm must be available (donated and/or cryopreserved sperm is allowed). Intracytoplasmic sperm injection (ICSI) will be allowed during this trial
• Body mass index 18 to 35 kg/m2, inclusive
• Able to understand the study
• Affiliation with a social security scheme
• Dated and signed inform consent

You may not qualify if:

• Altered ovarian reserve (Day3: FSH \>12 UI/l; AMH\<1,0 ng/ml; AFC\<8)
• History or presence of tumours of the hypothalamus or pituitary gland
• Presence of non isolated uni- or bilateral hydrosalpinx
• Abnormal gynaecological bleeding of undetermined origin
• Contraindication to being pregnant and/or carrying a pregnancy to term
• Known infection with human immunodeficiency virus, active hepatitis B or C virus in the female or male partner
• History or presence of ovarian, uterine or mammary cancer
• Known allergy or hypersensitivity to human gonadotropin preparations or to compounds that are structurally similar to any of the other medications administered during the trial
• Substance abuse that would interfere with trial conduct, as determined by the investigator
• Use of testicular or epididymal sperm
• Pregnant patient, nursing patient
• Participation in another ART clinical trial within the past 30 days
• Women who have risk to develop severe ovarian hyperstimulation syndrome (OHSS) during controlled ovarian stimulation (COS) defined as ≥ 18 follicles measuring 10 - 14 mm on the day of triggering
• Women with less than 3 follicles ≥ 15 mm on the triggering day or the day before the triggering
• Women with premature progesterone elevation during COS ( ≥1.5 ng/ml)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Cochin

Paris, 75014, France

Location

Related Publications (1)

• Zaat T, Zagers M, Mol F, Goddijn M, van Wely M, Mastenbroek S. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD011184. doi: 10.1002/14651858.CD011184.pub3.

  PMID: 33539543 DERIVED

MeSH Terms

Conditions

Infertility, Female; Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Khaled POCATE, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: November 22, 2017
• Study Start: September 24, 2018
• Primary Completion: January 19, 2022
• Study Completion: March 31, 2022
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

FR (1)