The Importance of Embryo Transfer Day Progesterone Value in Natural Cycle Frozen Embryo Transfers and the Evaluation of the Effect of Rescue Therapy on Pregnancy Outcomes in Patients With Low Progesterone Levels

NCT05481684 | Unknown

• 1 other identifier: 26.07.2022-E.71262
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 3

Brief Summary

Thanks to recent advances in clinical practice and laboratory, embryo cryopreservation has become the first-line procedure in assisted reproductive technology. Improved laboratory techniques have increased the number of available embryos derived from an in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle. Implementation of a single embryo transfer policy to improve vitrification, improve postwarm embryo survival rates, and reduce multiple pregnancies without reducing cumulative birth rates has contributed to an increase in the number of frozen-warms (1,2) Embryo freezing; It is becoming an adopted practice for an increasing number of indications, including prevention of ovarian hyperstimulation syndrome, preimplantation genetic testing (PGT), late follicular phase progesterone elevation, and embryo-endometrial asynchrony. In our study, we are investigating the effect of pre-transfer serum progesterone levels on pregnancy outcomes in patients who underwent frozen-thawed embryo transfer.Supplementary progesterone preparations can be used to prevent luteal phase defect and to provide progesterone support in cycle preparations for frozen-thawed embryo transfer(3). The aim in this study is to show the effect of serum progesterone level on the pregnancy results on the day of embryo transfer in natural cycles.

Conditions

Infertility; IVF; Progesterone

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rates

  fetal heartbeat by transvaginal ultrasound

  average of 1 year

Secondary Outcomes (2)

• Ongoing pregnancy rate

  average of 15 month

• Miscarriage

  average of 15 month

Study Arms (2)

Normal Progesterone group

EXPERIMENTAL

Progesterone level ≥ 10 ng/mL on ET day.

Other: Normal Progesterone group

Low Progesterone group

ACTIVE COMPARATOR

Progesterone level \<10 ng/mL on ET day. Grup a Rescue vaginal progesterone, Grup b Rescue subcutan progesterone

Other: Low Progesterone group

Interventions

Normal Progesterone group OTHER

No progesterone supplementation

Normal Progesterone group

Low Progesterone group OTHER

Progesterone level \<10 ng/mL on ET day. If serum progesterone levels were \<10 ng/ml at ET day, vaginal pills (Lutinus 2\*1) or SC progesterone daily (Prolutex) was given to patients and ET was performed on the same day. Progesterone supplementation was discontinued if there was no pregnancy. Progesterone supplementation at the same dose was continued until 10 gestational weeks for viable pregnancies.

Low Progesterone group

Eligibility Criteria

• Age: 20 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women between the ages of 20-42 who applied to the infertility clinic
• BMI\<30

You may not qualify if:

• Severe male factor (Sperm count \<5 ml/ml, progressively motile sperm count \<10%)
• Intrauterine structural anomalies not corrected by surgery
• Hydrosalpenx if not underwent surgery
• Refusal to participate in the study
• cycle cancelation

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (3)

Acıbadem Ataşehir Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Bezmialem Foundation University

Istanbul, Turkey (Türkiye)

RECRUITING

Novaart IVF and Women's Health Center

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Rienzi L, Gracia C, Maggiulli R, LaBarbera AR, Kaser DJ, Ubaldi FM, Vanderpoel S, Racowsky C. Oocyte, embryo and blastocyst cryopreservation in ART: systematic review and meta-analysis comparing slow-freezing versus vitrification to produce evidence for the development of global guidance. Hum Reprod Update. 2017 Mar 1;23(2):139-155. doi: 10.1093/humupd/dmw038.

  PMID: 27827818 RESULT

• Loutradi KE, Kolibianakis EM, Venetis CA, Papanikolaou EG, Pados G, Bontis I, Tarlatzis BC. Cryopreservation of human embryos by vitrification or slow freezing: a systematic review and meta-analysis. Fertil Steril. 2008 Jul;90(1):186-93. doi: 10.1016/j.fertnstert.2007.06.010. Epub 2007 Nov 5.

  PMID: 17980870 RESULT

• Groenewoud ER, Cohlen BJ, Macklon NS. Programming the endometrium for deferred transfer of cryopreserved embryos: hormone replacement versus modified natural cycles. Fertil Steril. 2018 May;109(5):768-774. doi: 10.1016/j.fertnstert.2018.02.135.

  PMID: 29778369 RESULT

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• pınar özcan, PhD

  Bezmialem Foundation University

  PRINCIPAL INVESTIGATOR

• Cem Demirel, PhD

  Acıbadem Ataşehir Hospital

  STUDY CHAIR

• Mehmet Erdem, PhD

  Novaart IVF and Women's Health Center

  STUDY CHAIR

Central Study Contacts

pınar özcan, PhD

CONTACT

+905414031625; pinarozcan@hotmail.com

cem demirel, PhD

CONTACT

+905309556505; cem.demirel@acibadem.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: August 8, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)