Status:
RECRUITING
PErsonalized Addition of Recombinant LH in Ovarian Stimulation
Lead Sponsor:
Fundación Santiago Dexeus Font
Collaborating Sponsors:
Merck, S.L., Spain
Conditions:
Infertility
Eligibility:
FEMALE
35-40 years
Phase:
PHASE4
Brief Summary
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 ooc...
Detailed Description
The main objective of assisted reproductive technology is to achieve a healthy child. Many aspects play a role in order to reach this outcome, including female age, the number of oocytes retrieved aft...
Eligibility Criteria
Inclusion
- Able and willing to sign the Patient Consent Form and adhere to study visitation schedule.
- ≥ 35 years ≤40 years old.
- AFC ≥5 and or AMH ≥1.2 ng/mL.
- \<4 or 4-9 oocytes retrieved in a previous IVF/ICSI cycle with a starting dose of ≤225 IU with any gonadotropin under a GnRH antagonist protocol.
- Up to 3 previous ovarian stimulation cycles with a starting dose of ≤225 IU in which dose adjustments during stimulation did not exceed 300 IU.
- Ovarian stimulation for IVF/ICSI
Exclusion
- Poor ovarian responders according to the Bologna criteria.
- Polycystic ovary syndrome (PCOS) patients according to the Rotterdam criteria.
- AFC\>20.
- Age \>40 or \<35 years old.
- Women with \>10 oocytes retrieved in a previous IVF/ICSI cycle with 150-225 IU starting dose.
- Women who required dose adjustments during stimulation \>300 IU with any gonadotropin in their previous cycle
- Uterine abnormalities.
- Recent history of any current untreated endocrine abnormality.
- Unilateral or bilateral hydrosalpinx (visible on ultrasound scan (USS), unless clipped).
- Contraindications for the use of medicine used for ovarian stimulation (gonadotropins, GnRH antagonist, progesterone vaginal gel)
- Recent history of severe disease requiring regular treatment (Clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment and patients with any contraindication to pregnancy).
- Preimplantation Genetic Testing for Aneuploidies (PGT-a).
- Testicular Sperm Aspiration or Testicular Sperm Extraction (TESA or TESE)
Key Trial Info
Start Date :
February 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04719000
Start Date
February 4 2021
End Date
November 1 2025
Last Update
May 22 2024
Active Locations (1)
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1
Hospital Universitario Quiron Dexeus
Barcelona, Spain, 08028