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NCT Number: NCT05969795

Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support

To evaluate whether single euploid embryo transfer in NC without routinely administered LPS is non-inferior to NC with routinely administered LPS.

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Key information

Conditions

Pregnancy Related Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

ART Fertility Clinics LLC, Abu Dhabi, United Arab Emirates

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About this study

In case the study will show that the live birth rate in single euploid NC frozen embryo transfer cycles without LPS is not inferior to NC cycles with LPS, treatment can be simplified, and participants comfort can be increased.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18 to 40 years
  • Regular ovulatory cycles
  • Availability of at least one euploid embryo after Trophectoderm biopsy for PGT-A on day 5 or day 6
  • Detection of ovulation by P4 rise > 1.0 ng/ml after LH surge
  • P4 value of at least 5 ng/ml on day 4 after ovulation

Exclusion criteria

  • History of repeated pre-menstrual spotting
  • Factors affecting the implantation through anatomical changes of the uterus / ovaries or the tubes (adenomyosis, Asherman syndrome, endometriosis, uterine fibroids / polyps, isthmocele with intracavitary fluid presence, hydrosalpinx….)

Treatment and study plan

Transvaginal ultrasound

Diagnostic Test

Intermittent transvaginal ultrasound throughout the cycle to monitor follicular growth

Serial serum LH, E2, P4

Diagnostic Test

Serial measurements of serum Luteinizing Hormone (LH), Estradiol (E2) and Progesterone (P4 )levels throughout the cycle to determine ovulation. LH-surge is identified when a rise of 180% above the previous level occurred and ovulation is confirmed with a decrease in E2 concentration, and a rise of progesterone level to ≥ 1.0 ng/ml (Irani et al., 2017).

Progesterone 100 Mg Vaginal Insert

Drug

On day of ET procedure, to administer 200 mg of vaginal progesterone and increase to 300 mg/day from the day after the ET onwards until the pregnancy test. In case of an implantation, vaginal P4 will be continued until 7 weeks of pregnancy

Other names: Progesterone 100Mg Vag Tab

Serum P4 day of ET - Control Group

Diagnostic Test

Serum P4 will be drawn before starting LPS in form of vaginal progesterone on the day of ET procedure

Serum P4 day of ET - Study Group

Diagnostic Test

Serum P4 will be drawn when study group participants are admitted to the clinic for the ET procedure.

Embryo transfer

Procedure

The procedure in which embryo is placed in the uterus.

Other names: ET

Serum hCG 10 days after ET

Diagnostic Test

Pregnancy will be confirmed / excluded by measurement of serum hCG 10 days after ET procedure and a level of > 15 IU will be regarded as positive result. The definitions of biochemical, ectopic, clinical and ongoing pregnancy follow the ICMART criteria (Zegers-Hochschild, 2006)

Serum P4 10 days after ET

Diagnostic Test

Serum P4 will be drawn on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure

Primary outcomes

  1. Implantation rate

    Time frame: 2 months

    Number of embryos which have produced ultrasonographic evidence of an intrauterine gestational sac per the total number of embryos transferred into the uterine cavity (Zegers-Hochschild et al., 2009).

  2. Clinical pregnancy rate

    Time frame: 2 months

    hCG > 15 Iu/ml and ultrasound confirmation of a gestational sac

  3. Live birth rate

    Time frame: 41 weeks

    Number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers (Zegers-Hochschild et al., 2009)

  4. Serum P4 levels on ET day

    Time frame: 1 day

    Progesterone level on the day of embryo transfer

  5. Serum E2 and P4 levels on day 5 or 6 after ET procedure

    Time frame: 6 days

    Estradiol and Progesterone levels on day 5 or 6 after embryo transfer

  6. Serum E2 and P4 levels on day 10 after ET procedure

    Time frame: 10 days

    Estradiol and Progesterone levels on day 10 after embryo transfer

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Lawrenz, PhD

CONTACT

[email protected]

+971 800 337845489

Jonalyn Edades, RN

CONTACT

[email protected]

+971 800 337845489

Sponsors and collaborators

Lead sponsor

ART Fertility Clinics LLC

Other

Registry information

Official study title

Comparison of Live Birth Rate (> 24 Weeks) in Natural Cycle (NC) Single Euploid Frozen Embryo Transfers (FET) With Versus Without Luteal Phase Support (LPS)

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2023
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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