Impact of Serum Progesterone in Modified Natural Cycles and Stimulated Cycles on Ongoing Pregnancy Rate

Infertility, Female Clinical Trial

— CORPUS-LUTEUM  

Official title:

Impact of Serum Progesterone Concentration on the Day of Embryo Transfer in Modified Natural Cycles and Stimulated Cycles on Ongoing Pregnancy Rate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04259996
• Other study ID #: 1907-VLC-075-EL
• Status: Completed
• Start date: February 19, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: October 2023
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Prospective cohort unicentric study including infertile patients undergoing an embryo transfer in the context of natural or stimulated cycles and receiving luteal phase support with vaginal natural progesterone following the clinical practice in our clinic in IVIRMA Valencia, Spain.

Description:

Progesterone as a promoter of endometrial maturation is essential for the process of embryo implantation. The transformation of the endometrium from a proliferative state to a receptive state depends on the adequate progesterone exposure of the endometrium. Therefore, in any assisted reproduction technique (ART) the management of the luteal phase with exogenous administered progesterone, aiming to achieve a receptive endometrial state, is an essential part of the therapy. This important part of infertility-treatment is called luteal phase support (LPS).

Currently, there is a scientific debate and research regarding the timing, the dose and route of administration of exogenous progesterone in ART cycles. For years, the administration of progesterone was based on a "one fits all"- concept, mainly driven from the doctors and patients' preference regarding dose, timing and route of administration of the exogenous progesterone. Due to the lack of solid and evidence-based knowledge, the LPS improving investigating LPS is of outmost importance.

Therefore, improving the LPS is continuously in the focus of research and investigation. Main objectives of those efforts are to clarify the optimal timing, dosage and route of administration of progesterone for every possible ART procedure, in order to improve therapy outcomes. Of special interest in this wide field is the management of LPS in embryo-transfer-cycles such as substituted cycles and modified natural cycles for frozen-thawed cycles, and in fresh embryo-transfers after stimulated cycles.

Measuring serum progesterone levels in the luteal phase of a transfer cycle seems to be a promising approach in resolving the former mentioned doubts. Now, research focuses on luteal-phase serum progesterone levels as a predictor of outcomes. The discovery of certain thresholds of progesterone levels in the serum would give us a handy tool for individualizing the LPS with the main objective to improve outcomes.

Previous studies could show that there exist certain thresholds of serum progesterone in substituted cycles that could be used as a predictor. Furthermore, the same group could show that modifying the dose and the route of administration in the sense of individualizing LPS can improve outcomes.

Considering those results, it remains to clarify if there also exist thresholds of serum progesterone in modified natural cycles and stimulated cycles and if it's possible to improve the results through individualization of LPS the same way as it has been shown for substituted cycles.

The intention of the present study is to carry out the determination of serum progesterone on the day of the embryo transfer to all those patients who are going to be subjected in IVIRMA Valencia to an embryo transfer in a modified natural cycle or a stimulated cycle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: July 1, 2023
• Est. primary completion date: July 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• The subject must provide written informed consent prior to any study related procedures

• Women =50 years old

• BMI = 40 kg/m2

• Adequate endometrial thickness (>6.5mm) and pattern (Triple A structure) in the proliferative phase

• Regular menstrual cycles

Exclusion Criteria:

• Uterine Pathology, adnexal pathology

• Systemic diseases

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Procedure:
• PROGESTERONE AND ESTRADIOL SERUM CONCENTRATION MEASUREMENT
The only intervention will be a single determination of serum P and E2 levels immediately before the embryo transfer.

Locations

Country	Name	City	State
Spain	Instituto Valenciano de Infertilidad Spain	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate	Presence or absence of ongoing pregnancy	12 months
Secondary	Implantation rate	Presence or absence of implantation	12 months
Secondary	Live Birth	Presence or absence of Live Birth	12 months
Secondary	Pregnancy Loss	Presence or absence of pregnancy loss	12 months