Clinical trial NCT03300518: Effectiveness of Estradiol Valerate Pretreatment in Antagonist Protocol for Poor Ovarian Response Patient
Official title: A Randomized Study to Analysis the Effectiveness of Estradiol Valerate Pretreatment in Antagonist Protocol for Poor Ovarian Response Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: GnRH antagonist
Estrogen pretreatment
Poor response patient
Lead sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2017-10-03
Enrollment: 552
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of study is to assess the efficacy of add-on estrogen pretreatment in GnRH antagonist protocol on oocyte retrieval as compared with GnRH antagonist protocol for patients with poor ovarian response Add-on estrogen pretreatment protocol is superior to none pretreatment GnRH antagonist protocol for the number of oocytes retrieval

Detailed description: Women of advanced maternal age seeking ART treatment are characterized as poor ovarian responders in the process of ovarian simulation. Poor response to ovarian stimulation causes high cycle cancellation rate and extremely low pregnancy rate.

More attention has been paid to the potential interest of steroid pretreatments in GnRH antagonist cycles; not only for scheduling the GnRH antagonist cycles, but also for synchronizing the follicular growth which may result in more oocytes retrieved. But available clinical results are controversial.

Previous studies have shown that utilizing the natural negative feedback of the hypothalamus-pituitary-ovary axis induced by estradiol valerate pretreatment effectively prevented inter-cycle increases in follicle-stimulating hormone, improved follicle synchronization, and resulted in a more coordinated follicular development, leading to the recovery of more mature oocytes. However none of the randomized controlled studies compared estradiol valerate pretreatment or not on treatment outcomes, ongoing pregnancy rate, directly on poor response patients using estradiol valerate pretreatment in GnRH antagonist protocol.

Eligibility criteria: Inclusion Criteria:Bologna criteria

* At least two of the following three features must be present:

  1. Advanced maternal age (≥40 years) or any other risk factor for POR
  2. A previous POR (≤3 oocytes with a conventional stimulation protocol)
  3. An abnormal ovarian reserve test (i.e. antral follicle count \< 5-7 follicles or AMH\< 0.5 - 1.1 ng/mL)

Exclusion Criteria:

1. Age ≥45 years,
2. Patients who conducted PGD/PGS, and donor egg cycles were excluded.
3. Presence of unilateral ovary absence
4. Abnormal uterine deformity or structure.
5. Spontaneous abortion patients with three or more (including biochemical pregnancy abortion)
6. With other endocrine disease, ovulation disorders such as adrenal cortex function or thyroid dysfunction
7. Have assisted reproductive technology contraindications or pregnancy contraindication of patients

Primary outcomes:
measure: The number of oocytes retrieved by the IVG 36 hours after hCG administration
timeFrame: 36 hours after hCG administration
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 6weeks
measure: ongoing pregnancy rate
timeFrame: 12weeks
measure: Optimal number of embryo
timeFrame: 1 week
Other outcomes:
Locations:
city: Changsha
country: China
facility: Reproductive & Genetic Hospital of Citic-Xiangya
state: Hunan
Study officials:
affiliation: Reproductive & Genetic Hospital of CITIC-Xiangya
name: Fei Gong, Doctor
role: STUDY_DIRECTOR
References:
citation: Zhang S, Tang Y, Wang X, Zong Y, Li X, Cai S, Ma H, Guo H, Song J, Lin G, Lu G, Gong F. Estrogen valerate pretreatment with the antagonist protocol does not increase oocyte retrieval in patients with low ovarian response: a randomized controlled trial. Hum Reprod. 2022 Jun 30;37(7):1431-1439. doi: 10.1093/humrep/deac081.