The Circadian Variability of Serum Progesterone During the Day of a Frozen Embryo Transfer

NCT05511272 | Completed DMC

• 1 other identifier: 1432022000124
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Serum progesterone levels will be evaluated at four different time points during the day of an artificially prepared frozen embryo transfer cycle (HRT FET cycle) and a modified natural cycle frozen embryo transfer cycle (mNC FET cycle) (at 08:00, 12:00, 16:00 and 20:00).The pairwise percentage differences in serum progesterone levels for each patient will be calculated. The intra-day variability of progesterone will be analyzed using mixed models. Pregnancy outcomes will also be assessed. The sample size calculated consisted of 22 patients for the HRT-FET study and 22 patients for the mNC FET study.

Conditions

Fertility Disorders

Outcome Measures

Primary Outcomes (1)

• The existence of circadian variability of serum progesterone during the day of a frozen embryo transfer

  To evaluate if there is significant variability in circadian level of serum progesterone on the day of an artificially prepared frozen embryo transfer cycle and during the day of a modified natural frozen embryo transfer cycle

  the day of the embryo transfer (from 8 am to 8 pm)

Secondary Outcomes (4)

• Pregnancy outcomes after the frozen embryo transfer

  from the day of the embryo transfer to 12 weeks of pregnancy

• The critical progesterone threshold to optimize pregnancy outcomes

  from the day of the embryo transfer to 12 weeks of pregnancy

• The assessment of serum progesterone on the day of frozen embryo transfer

  the day of the embryo transfer (from 8 am to 8 pm)

• Pregnancy outcomes after the frozen embryo transfer

  from the day of the embryo transfer to 7 weeks of pregnancy

Study Arms (1)

Frozen embryo transfer cycle

EXPERIMENTAL

Patients who will undergo a frozen embryo transfer in the modified natural cycle and in an artificially prepared cycle will be included

Biological: blood test

Interventions

blood test BIOLOGICAL

four blood samples will be withdrawn from the participants during the day of their frozen embryo transfer cycle

Frozen embryo transfer cycle

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 and ≤ 40 years old
• BMI ≥ 18.5 and ≤ 25,9 kg/m2
• The patient will undergo a hormone replacement therapy frozen embryo transfer cycle (HRT FET) or a modified natural cycle frozen embryo transfer cycle (mNC FET) according to the standard clinical practice in Brussels IVF
• In the HRT FET cycle the patient will be administered estradiol valerate and 6 days of micronized vaginal progesterone before the embryo transfer
• Adequate endometrial pattern (triple layer) and thickness (\>6.5 mm) at the moment of planning of the transfer
• Single blastocyst embryo transfer
• Signed informed consent
• Non-smokers

You may not qualify if:

• Age \> 40 (women \> 40 years old demonstrated an enhanced rate of absorption of progesterone using vaginal tablets compared to younger patients)
• BMI ≥ 26 (serum progesterone levels on the day of embryo transfer are lower in overweight and obese women compared to those with normal weight)
• Patients who need to take vaginal estradiol valerate during the HRT FET cycle
• Intake of any experimental drug or any participation in any other clinical trial within 30 days prior to study start
• Mental disability or any other lack of fitness, in the investigator's opinion, to preclude subjects in or to complete the study.
• Current or recent substance abuse, including alcohol and tobacco (patients who stopped tobacco usage at least 3 months prior to screening visit would be allowed)
• Refusal or inability to comply with the requirements of the study protocol for any reason, including scheduled clinic visits and laboratory tests.
• Embryo transfer after IVM cycle, PGT or oocyte acceptance
• Uterine pathologies (fibroids, polyps, chronic endometritis), uterine malformations (septum, Mullerian malformation) and hydrosalpinx

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Brussels IVF

Brussels, Jette, 1090, Belgium

Location

Related Publications (6)

• Mackens S, Santos-Ribeiro S, van de Vijver A, Racca A, Van Landuyt L, Tournaye H, Blockeel C. Frozen embryo transfer: a review on the optimal endometrial preparation and timing. Hum Reprod. 2017 Nov 1;32(11):2234-2242. doi: 10.1093/humrep/dex285.

  PMID: 29025055 BACKGROUND

• Melo P, Chung Y, Pickering O, Price MJ, Fishel S, Khairy M, Kingsland C, Lowe P, Petsas G, Rajkhowa M, Sephton V, Tozer A, Wood S, Labarta E, Wilcox M, Devall A, Gallos I, Coomarasamy A. Serum luteal phase progesterone in women undergoing frozen embryo transfer in assisted conception: a systematic review and meta-analysis. Fertil Steril. 2021 Dec;116(6):1534-1556. doi: 10.1016/j.fertnstert.2021.07.002. Epub 2021 Aug 10.

  PMID: 34384594 BACKGROUND

• Labarta E, Mariani G, Rodriguez-Varela C, Bosch E. Individualized luteal phase support normalizes live birth rate in women with low progesterone levels on the day of embryo transfer in artificial endometrial preparation cycles. Fertil Steril. 2022 Jan;117(1):96-103. doi: 10.1016/j.fertnstert.2021.08.040. Epub 2021 Sep 20.

  PMID: 34548167 BACKGROUND

• Wang Z, Liu H, Song H, Li X, Jiang J, Sheng Y, Shi Y. Increased Risk of Pre-eclampsia After Frozen-Thawed Embryo Transfer in Programming Cycles. Front Med (Lausanne). 2020 Apr 8;7:104. doi: 10.3389/fmed.2020.00104. eCollection 2020.

  PMID: 32322584 BACKGROUND

• Labarta E, Rodriguez-Varela C, Mariani G, Bosch E. Serum Progesterone Profile Across the Mid and Late Luteal Phase in Artificial Cycles Is Associated With Pregnancy Outcome. Front Endocrinol (Lausanne). 2021 Jun 10;12:665717. doi: 10.3389/fendo.2021.665717. eCollection 2021.

  PMID: 34177806 BACKGROUND

• Loreti S, Roelens C, Aktoz F, Niero M, De Munck N, Tournaye H, Mackens S, Blockeel C. Circadian serum progesterone variations on the day of frozen embryo transfer in a modified natural cycle protocol. Hum Reprod. 2024 May 22:deae101. doi: 10.1093/humrep/deae101. Online ahead of print.

  PMID: 38775072 DERIVED

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Christophe Blockeel, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 22, 2022
• Study Start: August 15, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 19, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)