eSET Plus Single Embryo Cryotransfer vs Double Embryo Transfer

• Sponsor: University Hospital Virgen de las Nieves (Other)
• Overall Status: Completed
• CT.gov ID: NCT01909570
• Collaborator: Instituto de Salud Carlos III (Other)
• Enrollment: 194
• Location: 1
• Arms: 2
• Duration (Months): 47
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Infertility; Pregnancy, Multiple	Procedure: Elective single embryo transfer; Procedure: Double embryo transfer	N/A

Detailed Description

The objective is to evaluate the In Vitro Fertilization/Intracytoplasmic Sperm Inyection (IVF/ICSI) results in terms of clinical pregnancy and multiple pregnancy rates, comparing elective single embryo transfer plus cryotransfer of one embryo if pregnancy is not achieved, with double embryo transfer.

This is a prospective randomized study, including couples arriving to the Reproductive Unit of the Hospital Universitario Virgen de las Nieves. All these patients had good reproductive prognosis and had been asigned randomly to one of the following groups: Group 1: elective single embryo transfer. In the case pregnancy is not achieved a cryotransfer of one embryo will be carried out. Group 2: elective double embryo transfer.

Study Design

• Study Type: Interventional
• Actual Enrollment: 194 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Randomized Clinical Trial Comparing Elective Single Embryo Transfer Plus Single Embryo Cryotransfer vs Double Embryo Transfer
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Elective single embryo transfer 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; 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.
Active Comparator: Double embryo transfer After the FIV/ICSI procedure, in this arm the embryo transfer woub be of two fresh embryos	Procedure: Double embryo transfer; After the FIV/ICSI procedure, the embryo transfer in this arm would be of two fresh embryos

Outcome Measures

Primary Outcome Measures

1. Clinical Pregnancy Rate [Seven weeks after embryo transfer]

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

Secondary Outcome Measures

1. Multiple Pregnancy Rate [Seven weeks after embryo transfer]

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

Other Outcome Measures

1. Live Birth Delivery Rate [38 weeks after embryo transfer]

   The delivery of a healthy child (o two)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 37 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• More tan five years of infertility

• Previous uterus surgery

• Uterus malformations

• More tan one miscarriage

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unidad de gestión clínica de ginecología y obstetricia. Instituto Biosanitario de Granada.Hospital Universitario Virgen de las Nieves	Granada		Spain	18014

Sponsors and Collaborators

• University Hospital Virgen de las Nieves
• Instituto de Salud Carlos III

Investigators

• Principal Investigator: Ana Clavero, PhD, Investigator and laboratory specialist

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ana Clavero Gilabert, PhD MD, University Hospital Virgen de las Nieves
• ClinicalTrials.gov Identifier: NCT01909570
• Other Study ID Numbers: FIS09/1968
• First Posted: Jul 26, 2013
• Last Update Posted: Jan 6, 2022
• Last Verified: Dec 1, 2021

• Additional relevant MeSH terms: Infertility

Study Results

Participant Flow

Recruitment Details	The recruitment period was from January 2010 to December 2012. The location of the recruitment was University Hospital of Virgen de las Nieves in Granada.
Pre-assignment Detail	A total of 194 women aged under 38 years were included in the study. Of these, 19 women were not randomised. The reasons were refusion to participate (n= 6), economic reasons (n = 2), participating in another study (n= 7) and not meeting criteria in further evaluation (n = 4).

Arm/Group Title	Elective Single Embryo Transfer	Double Embryo Transfer
Arm/Group Description	Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception	Transfer of two fresh embryos
Period Title: Overall Study
STARTED	84	91
COMPLETED	57	64
NOT COMPLETED	27	27

Baseline Characteristics

Arm/Group Title	Elective Single Embryo Transfer	Double Embryo Transfer	Total
Arm/Group Description	Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception	Transfer of two fresh embryos	Total of all reporting groups
Overall Participants	84	91	175
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.2 (3.6)	31.7 (3.8)	32.0 (3.7)
Sex: Female, Male (Count of Participants)
Female	84 100%	91 100%	175 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	84 100%	91 100%	175 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Spain	84 100%	91 100%	175 100%

Outcome Measures

1. Primary Outcome

Title	Clinical Pregnancy Rate
Description	A clinical pregnancy was defined by the presence of a gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy
Time Frame	Seven weeks after embryo transfer

Outcome Measure Data

Analysis Population Description

Women aged under 38 years, with BMI between 19-29 kg/m2, FSH <15mUI/mL on the third day and first cycle of IVF/ICSI or second cycle after a prior attempt with a positive pregnancy test result. The infertile period must be less of five years, without previous uterine surgery, uterine malformations, neither repeated spontaneous abortions.

Arm/Group Title	Elective Single Embryo Transfer	Double Embryo Transfer
Arm/Group Description	Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception	Transfer of two fresh embryos
Measure Participants	84	91
Number [percentage of pregnancy per transfer]	44.0	37.4

2. Secondary Outcome

Title	Multiple Pregnancy Rate
Description	A multiple clinical pregnancy was defined by the presence of more than one gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy
Time Frame	Seven weeks after embryo transfer

Outcome Measure Data

Analysis Population Description

Women aged under 38 years, with BMI between 19-29 kg/m2, FSH <15mUI/mL on the third day and first cycle of IVF/ICSI or second cycle after a prior attempt with a positive pregnancy test result. The infertile period must be less of five years, without previous uterine surgery, uterine malformations, neither repeated spontaneous abortions.

Arm/Group Title	Elective Single Embryo Transfer	Double Embryo Transfer
Arm/Group Description	Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception	Transfer of two fresh embryos
Measure Participants	84	91
Number [percentage of multiple pregnancies]	0	26.4

3. Other Pre-specified Outcome

Title	Live Birth Delivery Rate
Description	The delivery of a healthy child (o two)
Time Frame	38 weeks after embryo transfer

Outcome Measure Data

Analysis Population Description

Women aged under 38 years, with BMI between 19-29 kg/m2, FSH <15mUI/mL on the third day and first cycle of IVF/ICSI or second cycle after a prior attempt with a positive pregnancy test result. The infertile period must be less of five years, without previous uterine surgery, uterine malformations, neither repeated spontaneous abortions.

Arm/Group Title	Elective Single Embryo Transfer	Double Embryo Transfer
Arm/Group Description	Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception	Transfer of two fresh embryos
Measure Participants	84	91
Number [percentage of live birth]	45.2	41.8

Adverse Events

Arm/Group Title	Elective Single Embryo Transfer		Double Embryo Transfer
Arm/Group Description	Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception		Transfer of two fresh embryos
All Cause Mortality
	Elective Single Embryo Transfer		Double Embryo Transfer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Elective Single Embryo Transfer		Double Embryo Transfer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/84 (0%)		0/91 (0%)
Other (Not Including Serious) Adverse Events
	Elective Single Embryo Transfer		Double Embryo Transfer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/84 (3.6%)		5/91 (5.5%)
Pregnancy, puerperium and perinatal conditions
premature birth	3/84 (3.6%)	3	3/91 (3.3%)	3
Reproductive system and breast disorders
Hiperstimulation Ovarian Syndrome	0/84 (0%)	0	2/91 (2.2%)	2

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.