Status:
COMPLETED
Effect of Different Ovarian Stimulation Protocols on Endometrial Receptivity
Lead Sponsor:
Instituto Valenciano de Infertilidade de Lisboa
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Infertility, Female
Endometrial Diseases
Eligibility:
FEMALE
18-42 years
Phase:
PHASE4
Brief Summary
This study will assess the change in endometrial gene expression signature on the day of embryo transfer according to the type of exogenous gonadotropins administered.
Detailed Description
Late-follicular elevated progesterone (LFEP) following ovarian stimulation for assisted reproductive technologies (ART) has been linked to abnormal endometrial receptivity expression profiles and lowe...
Eligibility Criteria
Inclusion
- Informed consent form (ICF) dated and signed.
- Age: ≥18 and ≤42 years old.
- AFC \<20.
- AMH \<2.5 ng/mL, performed in the 12 months prior to inclusion.
- Body Mass Index (BMI): ≥18.5 Kg/m2 and \<30 Kg/m2.
- Weight: ≥50 kg and \<80 kg.
- First or second ART cycle (with pregnancy wish and planned for single blastocyst transfer) at the study site, or fertility preservation cycle.
- Regular menstrual cycles (between 22 and 35 days).
- Two ovaries present.
Exclusion
- Simultaneous participation in another clinical study.
- Previous history of poor ovarian response (\<4 oocytes retrieved) with a maximal dose of OS (≥300 IU/day) or OHSS, regardless of gonadotropin dose.
- Known reasons for impaired implantation (i.e. hydrosalpinx, fibroid distorting the endometrial cavity, Asherman's syndrome, thrombophilia or endometrial tuberculosis).
- Repeated miscarriages (\>2 previous biochemical pregnancies or \>2 spontaneous miscarriages).
- Recurrent implantation failure (\>3 failed cycles with good quality embryos).
- Polycystic ovary syndrome (PCOS).
- Tumours of the ovary, breast, uterus, pituitary or hypothalamus.
- Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
- Ovarian cysts or enlarged ovaries.
- Fibroid tumours of the uterus incompatible with pregnancy.
- Malformations of the reproductive organs incompatible with pregnancy.
- Primary gonadal failure.
- Renal impairment defined as estimated glomerular filtration rate of 90 ml/min/1.73 m2 determined by the Modified Diet and Renal Disease (MDRD) equation at screening.
- Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin).
- Risk factors for thromboembolic events, such as a personal or family history, severe obesity or thrombophilia.
- Moderate or severe hepatic impairment.
- Untreated and uncontrolled thyroid dysfunction.
- Current use of oral contraceptive, anti-depressants, anti-psychotics, steroids, anti-epileptics or chemotherapy.
- Administration of exogenous Estradiol (E2), Progesterone (P4) or gonadotropins in the preceding menstrual cycle.
- Active female smoking.
- Acceptors of donated oocytes/embryos.
- Ongoing pregnancy.
- Women who have previously enrolled in the trial.
- Those unable to comprehend the investigational nature of the proposed study.
Key Trial Info
Start Date :
January 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03755973
Start Date
January 29 2020
End Date
May 22 2023
Last Update
June 1 2023
Active Locations (1)
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1
Instituto Valenciano de Infertilidade
Lisbon, Portugal