Actively Recruiting

Phase 4
Age: 35Years - 40Years
FEMALE
NCT04719000

PErsonalized Addition of Recombinant LH in Ovarian Stimulation

Led by Fundación Santiago Dexeus Font · Updated on 2026-03-30

120

Participants Needed

1

Research Sites

351 weeks

Total Duration

On this page

Sponsors

F

Fundación Santiago Dexeus Font

Lead Sponsor

M

Merck, S.L., Spain

Collaborating Sponsor

AI-Summary

What this Trial Is About

Different ovarian stimulation regimens have shown to modify late follicular phase hormonal profiles. Besides, recent studies confirm that progesterone levels and their variation in the last day of oocyte maturation are affected by the dose of gonadotropins administered and by other factors. Progesterone elevation in late follicular phase of in vitro fertilization/intracytoplasmatic sperm injection (IVF/ICSI) cycles under ovarian stimulation compromises implantation rates due to a negative effect on the endometrium. However, there is still conflict in the literature questioning whether progesterone levels alone on the triggering day is a sufficient indicator as progesterone does not give the full picture of the ovarian functions, number of follicles as well as estrogen production that facilitate endometrial growth, thus some studies suggest that especially in aged and poor responders Progesterone/Estrogen (P4/E2) ratio has a better reflection (Progesterone (ng/mL) ×1,000/estradiol(pg/mL)) on the ovarian function. The scope of the current pilot study is to compare serum progesterone levels as well as P4/E2 ratio on the day of ovulation triggering of women belonging to POSEIDON category group 2 who undergo a new ovarian stimulation with a dose of rhFSH 300 IU or 300 IU rhFSH plus 150 IU recombinant human luteinizing hormone (rhLH) in a gonadotropin-releasing hormone (GnRH) antagonist protocol.

CONDITIONS

Official Title

PErsonalized Addition of Recombinant LH in Ovarian Stimulation

Who Can Participate

Age: 35Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Able and willing to sign the Patient Consent Form and follow the study visit schedule
  • Female aged 35 to 40 years old
  • Antral follicle count (AFC) of 5 or more and/or anti-Müllerian hormone (AMH) level of at least 1.2 ng/mL
  • Fewer than 4 or 4 to 9 oocytes retrieved in a previous IVF/ICSI cycle starting with 225 IU or less of gonadotropin under a GnRH antagonist protocol
  • Up to 3 previous ovarian stimulation cycles with starting doses of 225 IU or less and dose adjustments not exceeding 300 IU
  • Undergoing ovarian stimulation for IVF/ICSI
Not Eligible

You will not qualify if you...

  • Poor ovarian responders based on Bologna criteria
  • Polycystic ovary syndrome (PCOS) according to Rotterdam criteria
  • Antral follicle count (AFC) greater than 20
  • Age younger than 35 or older than 40 years
  • More than 10 oocytes retrieved in a previous IVF/ICSI cycle with 150-225 IU starting dose
  • Previous dose adjustments during stimulation exceeding 300 IU
  • Uterine abnormalities
  • Current untreated endocrine disorders
  • Unilateral or bilateral hydrosalpinx visible on ultrasound unless surgically clipped
  • Contraindications to ovarian stimulation medications (gonadotropins, GnRH antagonist, progesterone vaginal gel)
  • Recent severe disease requiring regular treatment or contraindications to pregnancy
  • Undergoing Preimplantation Genetic Testing for Aneuploidies (PGT-a)
  • Use of Testicular Sperm Aspiration or Extraction (TESA or TESE)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Hospital Universitario Quiron Dexeus

Barcelona, Spain, 08028

Actively Recruiting

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Research Team

N

Nikolaos P Polyzos, MD PhD

CONTACT

I

Ignacio Rodríguez, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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