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

NCT04259996 | Completed

• 1 other identifier: 1907-VLC-075-EL
• Study Type: observational
• Target: 488
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility, Female

Keywords

Progesterone in luteal phase; modified natural cycle; stimulated cycle; clinical pregnancy rate; live birth rate

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

  Presence or absence of ongoing pregnancy

  12 months

Secondary Outcomes (3)

• Implantation rate

  12 months

• Live Birth

  12 months

• Pregnancy Loss

  12 months

Study Arms (2)

MODIFIED NATURAL CYCLE

The term 'modified natural cycle' refers to a natural cycle in which ovulation is triggered by exogenous hCG administration in order to provide optimal timing scheduling embryo transfer. In contrast to the natural cycle, the applied hCG may lead to a different luteal phase profile. Luteal phase support is common clinical practice in those cycles. On the day of embryo transfer (ET), eligible patients being transferred one or two good quality embryos on day 5 of development according to the Spanish ASEBIR classification will be informed about the nature of the study, read the informed consent (IC) form and decide if entering into the study. After signing the IC form, a blood test will be performed in a time frame between 1 and 2 hours before the ET. The only intervention will be a single determination of serum P and E2 levels immediately before the embryo transfer.

Procedure: PROGESTERONE AND ESTRADIOL SERUM CONCENTRATION MEASUREMENT

STIMULATED CYCLE

On the day of embryo transfer (ET), eligible patients being transferred one or two good quality embryos on day 5 of development according to the Spanish ASEBIR classification will be informed about the nature of the study, read the informed consent (IC) form and decide if entering into the study. After signing the IC form, a blood test will be performed in a time frame between 1 and 2 hours before the ET. The only intervention will be a single determination of serum P and E2 levels immediately before the embryo transfer.

Procedure: PROGESTERONE AND ESTRADIOL SERUM CONCENTRATION MEASUREMENT

Interventions

PROGESTERONE AND ESTRADIOL SERUM CONCENTRATION MEASUREMENT PROCEDURE

The only intervention will be a single determination of serum P and E2 levels immediately before the embryo transfer.

MODIFIED NATURAL CYCLE; STIMULATED CYCLE

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All infertile patients undergoing a fresh or frozen blastocyst transfer (two blastocysts transferred as maximum) from own or donated oocytes; in the context of a modified natural cycle (group A) or a stimulated cycle (group B). As usually performed in our daily clinical practice, all patients will receive hCG to trigger ovulation and maintain the corpus luteum to produce endogenous progesterone. Luteal phase support will be given as usual according to the routine in our center.

You may qualify if:

• 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

You may not qualify if:

• Uterine Pathology, adnexal pathology
• Systemic diseases

Sponsors & Collaborators

• Instituto Valenciano de Infertilidad, IVI VALENCIA: lead

Study Sites (1)

Instituto Valenciano de Infertilidad Spain

Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Progesterone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Elena Labarta, MD

  IVIRMA VALENCIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 7, 2020
• Study Start: February 19, 2020
• Primary Completion: July 25, 2022
• Study Completion: July 1, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)