NCT05721495

Brief Summary

Single embryo transfer decreases the multiple pregnancy rate and its complications. However, studies are needed to help increase the effectiveness of this technique to increase its use, which undoubtedly improves the safety of our patients. Objectives: To assess the results of IVF / ICSI cycles with single embryo transfer, in terms of both pregnancy and live birth rates, comparing a group of patients in which an elective delayed cryotransfer of an embryo without fresh transfer is performed (experimental group ), with patients in whom a fresh embryo is transferred electively. Methodology: A prospective randomized clinical trial with two arms in parallel, not blinded, including 138 couples using an IVF / ICSI cycle at the Reproduction Unit of the Hospital Universitario Virgen de las Nieves de Granada. The inclusion criteria classify them as having a good reproductive prognosis, and the patients will follow an ovulation treatment protocol with GnRH agonists or antagonists. Couples will undergo an IVF / ICSI cycle, randomly assigned to:

  • Group I (experimental): fresh transfer is not performed, the best quality embryo is cryopreserved. Elective transfer in a later cycle of the cryopreserved embryo.
  • Group II (control): fresh transfer of the best quality embryo.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
Last Updated

February 10, 2023

Status Verified

January 1, 2023

Enrollment Period

4.5 years

First QC Date

December 16, 2022

Last Update Submit

January 31, 2023

Conditions

Single Embryo TransferEmbryo Implantation, DelayedPregnancy Rate

Outcome Measures

Primary Outcomes (1)

  • Live birth rate

    Live birth rate after freeze-all or fresh embryo strategy in an Assisted Reproduction program

    15 months

Secondary Outcomes (9)

  • Metaphase II rate

    1 month

  • Fertility rate

    1 month

  • Good embryo quality rate

    1 month

  • Survival to devitrification rate

    4 months

  • Gestation rate

    4 months

  • +4 more secondary outcomes

Study Arms (2)

Freeze all strategy embryo transfer

EXPERIMENTAL

Three days after fecundation, the best embryo is criopreserved. It is transferred in a posterior cicle

Other: freeze all strategy embryo transfer

Fresh embryo transfer strategy

ACTIVE COMPARATOR

Two or three days after fecundation, the best embryo is transferred.

Other: fresh embryo transfer strategy

Interventions

freeze all strategy embryo transferOTHER

criopreservation of all viable embryos in order to transfere the best one in a posterior cycle

Freeze all strategy embryo transfer
fresh embryo transfer strategyOTHER

transfer of the best embryo two or three days after the fecundation technique

Fresh embryo transfer strategy

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 19-29 kg/m2
  • AMH \> 0.5 ng/mL
  • FIV/ICSI cycle: first or second

You may not qualify if:

  • uterus surgery
  • endometriosis
  • miscarriage \>1
  • REM \< 1 million spz

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Virgen de las Nieves

Granada, 18014, Spain

Location

Study Officials

  • Ana Clavero-Gilabert, PhD

    HU Virgen de las Nieves

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The study arm is masked until the oocyte recovery date, when we have to give a date in the control arm for the embryo transfer.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized clinical trial with two parallel arms
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Clinical laboratory especialist

Study Record Dates

First Submitted

December 16, 2022

First Posted

February 10, 2023

Study Start

September 1, 2017

Primary Completion

February 28, 2022

Study Completion

November 30, 2022

Last Updated

February 10, 2023

Record last verified: 2023-01

Locations

ES(1)