Synchronizing Blastocyst in Frozen Embryo Transfer

Synchronizing Blastocyst at Hatching Stage in Frozen Embryo Transfer Cycles

The aim of the present study is to determine if implantation rate could be increased in women undergoing frozen embryo transfer cycles in case of adjusting their embryo development at hatching stage.

Study Overview

• Status: Completed
• Conditions: Embryo Implantation
• Intervention / Treatment: Other: synchronizing blastocysts

• Study Type: Interventional
• Enrollment (Actual): 742
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Banhā, Egypt
    • Al-Yasmeen fertility and gynecology center
  • Cairo, Egypt
    • Ganna Fertility and Gynecology Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Patients who will agree to participate and assign an informed consent form
2. Only blastocyst transfer FET cycles
3. Patients undergoing FET after their 1st IVF or ICSI cycle with no pregnancy at the fresh transfer
4. Freeze-all cycles due to OHSS
5. Freeze-all cycles due to poor endometrium
6. Age 19-33 at the time of randomization.
7. Their frozen blastocysts are 3 or less grade of expansion.
8. Female with a ≥12 AFCs
9. Endometrial thickness ≥ 8mm at the time of ovulation
10. Women with their male partners will give only fresh semen
11. Women who have no uterine abnormality by ultrasound
12. BMI ≤ 31

Exclusion Criteria:

1. Cycles undergoing preimplantation genetic diagnosis.
2. Women who have previous two cycles of implantation failure at fresh transfer
3. Women who have previous two FET failed cycles
4. Any uterine pathology (myomas, adenomyosis, endocrinopathies, thrombophilia, chronic pathologies, acquired or congenital uterine abnormalities)
5. Patients with severe endometriosis
6. Presence of uni- or bilateral hydrosalpinx
7. Recurrent pregnancy loss.
8. Any medical condition that affect fertility.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: frozen/thawed; blastocysts with three or less grade of expansion will be thawed and then subsequently transferred into women uterus three hours post-thawing.
Experimental: synchronized frozen/thawed hatching blastocysts; blastocyst thawing (with three or less grade of expansion) will take place the day before embryo transfer in order to reach hatching stage	Other: synchronizing blastocysts; transferring frozen/thawed a synchronized blastocysts at hatching stage into female uterus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ongoing implantation rate	ultrasound detection of ongoing gestational sacs with heartbeats after 12 weeks of gestation per transferred embryos	12 weeks

Collaborators and Investigators

• Sponsor: Al-Yasmeen Fertility and Gynecology Center
• Collaborators: Ganna Fertility Center

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2017
• Primary Completion (Actual): January 15, 2018
• Study Completion (Actual): May 10, 2018

Study Registration Dates

• First Submitted: April 21, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): June 27, 2019
• Last Update Submitted That Met QC Criteria: June 25, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 001-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No