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NCT03300518·Not applicable·INTERVENTIONAL

Effectiveness of Estradiol Valerate Pretreatment in Antagonist Protocol for Poor Ovarian Response Patient

GanirelixOtherCompleted

Status

Completed

Phase

Not applicable

Enrollment

552

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

DRUG

Follitropin Beta;MSD

Patients will start stimulation with a daily s.c. injection of follitropin beta( 300IU Puregonon;MSD) menstrual cycle day 2 or 3.

DRUG

Ganirelix

A daily administration of ganirelix (0.25 mg Orgalutran; MSD) was introduced when the leading follicle is near 13mm, and was repeated up to the time of hCG administration.

DRUG

hCG

Ovulation was triggered when the leading follicles reach 18-20mm and at least two follicles 17-18mm , HCG 10000 IU is used to trigger

DRUG

estradiol valerate

Estradiol valerate (progynova,Schering) daily dose of 4 mg (2 mg twice a day) was given orally, started 7 days before the presumed onset of menses and administered up to 2 days of the next menstrual cycle

Timeline

From registration to results.

  1. First posted

    Oct 3, 2017

  2. Study start

    Nov 15, 2017

  3. Primary completion

    Jun 18, 2021

  4. Study completion

    Aug 18, 2021

  5. Results posted

    Not reported

  6. Registry updated

    Jan 11, 2022

Outcomes

What the study measures.

Primary outcomes

The number of oocytes retrieved by the IVG 36 hours after hCG administration

Time frame · 36 hours after hCG administration

The total MII oocytes retrievedd

Secondary outcomes

Clinical pregnancy rate

Time frame · 6weeks

clinical pregnancy, defined as intrauterine pregnancy with a positive heartbeat at 6 weeks of gestation.Clinical pregnancy rate:Number of clinical pregnancies expressed per 100 initiated cycles, aspiration cycles, or embryo transfer cycles. When clinical pregnancy rates are given, the denominator must be specified.

ongoing pregnancy rate

Time frame · 12weeks

ongoing pregnancy defined as an intact pregnancy at 12 weeks of gestation

Optimal number of embryo

Time frame · 1 week

According to the embryonic developmental rate and morphology, the high quality embryos were defined as the next day (D2) transplanted embryos reached 3 or 4 cells and the third day (D3) transplanted embryos reached 6 to 8 cells with morphological grade 1 or 2

Eligibility

Who can take part.

Minimum age
40 Years
Maximum age
45 Years
Sex
FEMALE
Healthy volunteers
No

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

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Reproductive & Genetic Hospital of Citic-Xiangya

Changsha, Hunan, China

Publications

Results and literature.

PMID 35460400 ↗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.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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