Comparing the Ongoing Pregnancy Rate for Vitrification of Day-4 Morula With Day-5 Blast

NCT03787901 | Terminated DMC

• 1 other identifier: EFRE Vitrification Trial
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 4

Brief Summary

Comparing the vitrification at Day-4 (morula stage) with the blastocyst stage vitrification outcomes with the transfer of all day 5 after warming seems need evaluation. To the best of our knowledge, there has been no random-controlled trial conducted such comparison. Altogether, this trial is to evaluate the morula stage vitrification to blastocyst vitrification on the ongoing pregnancy rate after ICSI.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• The ongoing pregnancy rate

  Continued pregnancy at \> gestational week 12 or more per initiated cycle

  12 weeks

Secondary Outcomes (8)

• Biochemical pregnancy rate

  14 days

• Implantation rate

  12 weeks

• Cumulative implantation rate

  One year

• Clinical pregnancy rate

  7 weeks

• Cumulative clinical pregnancy rate

  One year

Study Arms (2)

Morula Vitrification Arm

EXPERIMENTAL

Other: Morula Vitrification

Blastocyst Vitrification Arm

ACTIVE COMPARATOR

Other: Morula Vitrification

Interventions

Morula Vitrification OTHER

Evaluating the ongoing pregnancy rate following Morula vitrification compared with Blastocyst Vitrification.

Blastocyst Vitrification Arm; Morula Vitrification Arm

Eligibility Criteria

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

You may qualify if:

• Women age of ≥ 18 to ≤ 40
• BMI of ≤ 31
• Normal responder (≥ 12 antral follicle count (AFC) during basal ultrasound examination) or hyper responder
• The freeze-all groups including PCOS, OHSS, or high Progesterone at trigger day
• Women who have ≥ 1 year of primary or secondary infertility
• Tubal factor (unilateral, bilateral obstruction or salpingectomy)
• Fresh semen ejaculates but not frozen or surgically retrieved sperm
• Male factor: oligoasthenozoospermia but not globozoospermia or pinhead sperm
• Women who are undergoing their first or second ICSI attempts with a previously successful attempt
• Women who undergo only freeze-all embryo
• Freeze-all for poor endometrium at the fresh cycle
• Freeze-all due to abnormal endometrial findings such as polyp or myoma with a decision for freeze all for surgical correction.
• Women who have normal endometrial thickness (≥ 8) and echo-pattern at the time of progesterone start in the proposed vitrified warmed cycle

You may not qualify if:

• Women who have uncorrectable uterine pathology or abnormality including submucous myoma
• Women or their husbands who have abnormal karyotyping
• Women with a history of recurrent abortions or repeated implantation failures
• Women who have uncontrolled diabetes
• Women with diagnosed or undiagnosed liver or renal disease
• Women who had a history of malignancy or borderline pathology
• Women who will refuse to participate in the study
• Women with endometriosis
• Patient undergoing PGS or PGD
• Surgically retrieved, frozen-thawed and pinpoint sperm or globozoospermia
• Adenomyosis
• Severe medical condition

Sponsors & Collaborators

• Egyptian Foundation of Reproductive Endocrinology: lead
• Al Hayat ICSI Centre of Alexandria, Egypt: collaborator
• Agial IVF/ICSI Unit of Alexandria, Egypt: collaborator
• Al Madina Fertility centre of Alexandria, Egypt: collaborator
• Rahem Fertility Center of Zagazig, Egypt: collaborator

Study Sites (4)

Agial

Alexandria, 12345, Egypt

Location

Al Hayat ICSI Centre of Alexandria

Alexandria, 12345, Egypt

Location

AlMadina IVF and ICSI Centre

Alexandria, 12345, Egypt

Location

Rahem Fertility Centre of Zagazig

Zagazig, 12345, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Director, Al Hayat ICSI Centre of Alexandria, Egypt

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 26, 2018
• Study Start: January 15, 2019
• Primary Completion: May 31, 2020
• Study Completion: June 1, 2020
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (4)