Optimal Timing of Euploid Day 6 Blastocyst Transfer in Frozen HRT Cycles, Day 6 or Day 7 of Progesterone Administration.

NCT05980091 | Recruiting Phase 1 DMC

• 1 other identifier: 2306-ABU-013-CC
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to compare the difference in clinical pregnancy, miscarriage and livebirth rate between day 6 euploid blastocyst transfer on the 6th and the 7th day of progesterone exposure in Hormonal Replacement Therapy (HRT) FET cycles. This prospective \& randomized study will only include euploid day 6 blastocysts. This will be the first prospective study of euploid day 6 blastocysts thereby excluding aneuploidy as a cause of miscarriage and implantation failure. The point of randomization will occur on the day of progesterone commencement.

Conditions

Infertility; Fertility Issues; Infertility, Female

Keywords

Implantation; Infertility; Blastocyst; HRT; Progesterone

Outcome Measures

Primary Outcomes (1)

• Livebirth rate (LBR)

  Defined as the delivery of a live infant born after 24 completed weeks of gestation

  41 weeks

Secondary Outcomes (4)

• Biochemical pregnancy rate

  5 weeks

• Clinical pregnancy rate

  5 weeks

• Ongoing pregnancy rate after 12 weeks

  13 weeks

• Miscarriage rate

  24 weeks

Study Arms (2)

Group A

OTHER

Embryo transfer is scheduled on the 6th full day of progesterone administration, following the initial commencement of progesterone (120 hours)

Diagnostic Test: Transvaginal ultrasound; Diagnostic Test: Serum LH, E2, P4; Drug: Estradiol Valerate 2 MG; Drug: Progesterone 100 Mg Vaginal Insert; Diagnostic Test: Serum P4 day of ET; Procedure: Embryo transfer

Group B

OTHER

Embryo Transfer is scheduled on the 7th full day of progesterone administration, following the initial commencement of progesterone (144 hours)

Diagnostic Test: Transvaginal ultrasound; Diagnostic Test: Serum LH, E2, P4; Drug: Estradiol Valerate 2 MG; Drug: Progesterone 100 Mg Vaginal Insert; Diagnostic Test: Serum P4 day of ET; Procedure: Embryo transfer

Interventions

Transvaginal ultrasound DIAGNOSTIC_TEST

Transvaginal ultrasound throughout the HRT cycle to not only monitor endometrial development but to also exclude the presence of an ovarian dominant follicle

Group A; Group B

Serum LH, E2, P4 DIAGNOSTIC_TEST

In conjunction with ultrasound monitoring, participants will undergo serial measurements of serum Luteinizing Hormone (LH), Estradiol (E2) and Progesterone (P4) levels

Group A; Group B

Estradiol Valerate 2 MG DRUG

Participants will commence estradiol valerate 4 mg ( 2 x 2 mg) on day 2 / day 3 of menses. Estradiol will be increased to 6 mg on day 2 of estrogen treatment, and continued at a daily dose of 6 mg (3 tablets daily)

Also known as: Estradiol Valerate

Group A; Group B

Progesterone 100 Mg Vaginal Insert DRUG

The initial progesterone dose of 100 mg will be commenced at 13hrs and repeated at 21hrs considered day 1 (vaginal suppository) when an optimal endometrial thickness for each participant has been achieved with a trilaminar appearance. The following day (day 2) progesterone administration will be increased to 100 mg vaginally three times daily

Also known as: Progesterone 100 mg

Group A; Group B

Serum P4 day of ET DIAGNOSTIC_TEST

On the day of embryo transfer (ET), a blood test is taken to measure serum P4

Group A; Group B

Embryo transfer PROCEDURE

Procedure in which embryo is transferred into the uterus

Also known as: ET

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 43 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18 years to 43 years.
• Having at least 1 euploid cryopreserved day 6 blastocyst of at least Grade BB quality.
• Endometrial trilaminar appearance on the day of progesterone start

You may not qualify if:

• Uterine abnormality
• Hydrosalpinx
• Asherman syndrome
• Any known contraindications or allergy to oral estradiol or progesterone.
• Spontaneous ovulation HRT cycle
• Discontinuation of HRT medication

Sponsors & Collaborators

• ART Fertility Clinics LLC: lead

Study Sites (2)

ART Fertility Clinics LLC

Abu Dhabi, Abu Dhabi Emirate, 60202, United Arab Emirates

RECRUITING

ART Fertility Clinics Dubai

Dubai, United Arab Emirates

RECRUITING

Related Publications (7)

• Franasiak JM, Ruiz-Alonso M, Scott RT, Simon C. Both slowly developing embryos and a variable pace of luteal endometrial progression may conspire to prevent normal birth in spite of a capable embryo. Fertil Steril. 2016 Apr;105(4):861-6. doi: 10.1016/j.fertnstert.2016.02.030.

  PMID: 26940791 BACKGROUND

• Nawroth F, Ludwig M. What is the 'ideal' duration of progesterone supplementation before the transfer of cryopreserved-thawed embryos in estrogen/progesterone replacement protocols? Hum Reprod. 2005 May;20(5):1127-34. doi: 10.1093/humrep/deh762. Epub 2005 Feb 3.

  PMID: 15695314 BACKGROUND

• van de Vijver A, Drakopoulos P, Polyzos NP, Van Landuyt L, Mackens S, Santos-Ribeiro S, Vloeberghs V, Tournaye H, Blockeel C. Vitrified-warmed blastocyst transfer on the 5th or 7th day of progesterone supplementation in an artificial cycle: a randomised controlled trial. Gynecol Endocrinol. 2017 Oct;33(10):783-786. doi: 10.1080/09513590.2017.1318376. Epub 2017 Apr 26.

  PMID: 28443690 BACKGROUND

• Zegers-Hochschild F, Adamson GD, Dyer S, Racowsky C, de Mouzon J, Sokol R, Rienzi L, Sunde A, Schmidt L, Cooke ID, Simpson JL, van der Poel S. The International Glossary on Infertility and Fertility Care, 2017. Fertil Steril. 2017 Sep;108(3):393-406. doi: 10.1016/j.fertnstert.2017.06.005. Epub 2017 Jul 29.

  PMID: 28760517 BACKGROUND

• Roelens C, Santos-Ribeiro S, Becu L, Mackens S, Van Landuyt L, Racca A, De Vos M, van de Vijver A, Tournaye H, Blockeel C. Frozen-warmed blastocyst transfer after 6 or 7 days of progesterone administration: impact on live birth rate in hormone replacement therapy cycles. Fertil Steril. 2020 Jul;114(1):125-132. doi: 10.1016/j.fertnstert.2020.03.017. Epub 2020 Jun 16.

  PMID: 32553469 BACKGROUND

• Bourdon M, Pocate-Cheriet K, Finet de Bantel A, Grzegorczyk-Martin V, Amar Hoffet A, Arbo E, Poulain M, Santulli P. Day 5 versus Day 6 blastocyst transfers: a systematic review and meta-analysis of clinical outcomes. Hum Reprod. 2019 Oct 2;34(10):1948-1964. doi: 10.1093/humrep/dez163.

  PMID: 31644803 BACKGROUND

• Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Hudson C. Clinical rationale for cryopreservation of entire embryo cohorts in lieu of fresh transfer. Fertil Steril. 2014 Jul;102(1):3-9. doi: 10.1016/j.fertnstert.2014.04.018. Epub 2014 May 17.

  PMID: 24842675 BACKGROUND

MeSH Terms

Conditions

Infertility; Infertility, Female

Interventions

Estradiol; Progesterone; Embryo Transfer

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnenediones; Pregnenes; Pregnanes; Corpus Luteum Hormones; Progesterone Congeners; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Carol Coughlan, PhD

  ART Fertility Clinics LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Lawrenz, PhD

CONTACT

+971 800 337845489; barbara.lawrenz@artfertilityclinics.com

Jonalyn Edades, RN

CONTACT

+971 800 337845489; jonalyn.edades@artfertilityclinics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 7, 2023
• Study Start: September 22, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

AE (2)