eSET Plus Single Embryo Cryotransfer vs Double Embryo Transfer

NCT01909570 | Completed Results

• 1 other identifier: FIS09/1968
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a policy of elective single embryo transfer (eSET) plus single embryo cryotransfer is as effective as a double embryo transfer in terms of clinical pregnancy rate

Conditions

Infertility; Pregnancy, Multiple

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy Rate

  A clinical pregnancy was defined by the presence of a gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy

  Seven weeks after embryo transfer

Secondary Outcomes (1)

• Multiple Pregnancy Rate

  Seven weeks after embryo transfer

Other Outcomes (1)

• Live Birth Delivery Rate

  38 weeks after embryo transfer

Study Arms (2)

Elective single embryo transfer

EXPERIMENTAL

After the FIV/ICSI procedure, in this arm the embryo transfer would be of a single embryo followed by the cryotransfer or a single embryo in case of no fresh conception

Procedure: Elective single embryo transfer

Double embryo transfer

ACTIVE COMPARATOR

After the FIV/ICSI procedure, in this arm the embryo transfer woub be of two fresh embryos

Procedure: Double embryo transfer

Interventions

Elective single embryo transfer PROCEDURE

After the FIV/ICSI procedure, the embryo transfer in this arm would be of one embryo followed by the cryotransfer of one embryo in case of no conception in the fresh cycle.

Elective single embryo transfer

Double embryo transfer PROCEDURE

After the FIV/ICSI procedure, the embryo transfer in this arm would be of two fresh embryos

Double embryo transfer

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women less tan 38 years
• women Body Mass Index (BMI) between 19-39 kg/m2
• Follicle-Stimulating Hormone (FSH) \<15 mUI/mL on cycle third day
• First IVF/ICSI cycle or second after a positive pregnancy test in the first one

You may not qualify if:

• More tan five years of infertility
• Previous uterus surgery
• Uterus malformations
• More tan one miscarriage

Sponsors & Collaborators

• University Hospital Virgen de las Nieves: lead
• Instituto de Salud Carlos III: collaborator

Study Sites (1)

Unidad de gestión clínica de ginecología y obstetricia. Instituto Biosanitario de Granada.Hospital Universitario Virgen de las Nieves

Granada, 18014, Spain

Location

Related Publications (1)

• Lopez-Regalado ML, Clavero A, Gonzalvo MC, Serrano M, Martinez L, Mozas J, Rodriguez-Serrano F, Fontes J, Castilla JA. Randomised clinical trial comparing elective single-embryo transfer followed by single-embryo cryotransfer versus double embryo transfer. Eur J Obstet Gynecol Reprod Biol. 2014 Jul;178:192-8. doi: 10.1016/j.ejogrb.2014.04.009. Epub 2014 Apr 19.

  PMID: 24798072 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Limitations and Caveats

Our study could have been complemented by improved embryo selection, using a time-lapse system. Another limitation of our study is that after devitrification, blastocyst culture was not performed.

Results Point of Contact

• Title: Dr. Ana Clavero
• Organization: University Hospital Virgen de las Nieves

anaclaverogilabert@gmail.com

0034958020482

Study Officials

• Ana Clavero, PhD

  Investigator and laboratory specialist

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD MD

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: July 26, 2013
• Study Start: January 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 16, 2024
• Results First Posted: February 20, 2015

Record last verified: 2024-05

Locations

ES (1)