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InfertilityNCT03300518

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

A study testing Follitropin Beta;MSD, Ganirelix and hCG in people with Infertility, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 45 years, women only
Conditions the study is for
Infertility
What is being tested?
Follitropin Beta;MSD, Ganirelix and hCG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
552 participants
Where
1 siteChina
Study dates
15 Nov 2017to 18 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • At least two of the following three features must be present:
  • Advanced maternal age (≥40 years) or any other risk factor for POR
  • A previous POR (≤3 oocytes with a conventional stimulation protocol)
  • An abnormal ovarian reserve test (i.e. antral follicle count < 5-7 follicles or AMH< 0.5 - 1.1 ng/mL)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Reproductive & Genetic Hospital of Citic-Xiangya

    Changsha, Hunan

Other trials in China

About this study

Official title: A Randomized Study to Analysis the Effectiveness of Estradiol Valerate Pretreatment in Antagonist Protocol for Poor Ovarian Response Patient

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

Read the 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.

Conditions
Infertility
Being tested
Follitropin Beta;MSD, Ganirelix, hCG, estradiol valerate
Keywords
GnRH antagonist, Estrogen pretreatment, Poor response patient
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Follitropin Beta;MSDDrug

    Also called Puregon

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

  • GanirelixDrug

    Also called Orgalutran

    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.

  • hCGDrug

    Also called Ovidrel

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

  • estradiol valerateDrug

    Also called progynova

    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

Study groups in NCT03300518
Study groupRoleWhat they receive
pretreatment groupOtherthe pretreatment group underwent a modified treatment protocol with pretreatment with estogen administering during the cycle preceding the IVF/ICSI cycle. daily dose of 4 mg (2 mg twice a day) estradiol valerate was given orally in the middle luteal phase which is confirmed seven days after ovulation monitoring by the ultrasound up to 2 days of the next menstrual cycle.Recombinant FSH (Puregon) was initiated on menstrual cycle day 2- 3 at an initial dose of 300 IU/day.A daily administration of ganirelix (0.25 mg Orgalutran; Organon) was introduced when the leading follicle is near 13mm, and was repeated up to the time of hCG administration.Ovulation was triggered when the leading follicles reach 18-20mm and at least two follicles 17-18mm , HCG 10000 IU is used to trigger.
Receives: Drug: Follitropin Beta;MSD; Drug: Ganirelix; Drug: hCG; Drug: estradiol valerate
control groupsOtherIn the control groups standard GnRH-antagonist protocol was applied.Recombinant FSH (Puregon) was initiated on menstrual cycle day 2- 3 at an initial dose of 300 IU/day.A daily administration of ganirelix (0.25 mg Orgalutran; Organon) was introduced when the leading follicle is near 13mm, and was repeated up to the time of hCG administration.Ovulation was triggered when the leading follicles reach 18-20mm and at least two follicles 17-18mm , HCG 10000 IU is used to trigger.
Receives: Drug: Follitropin Beta;MSD; Drug: Ganirelix; Drug: hCG

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The total MII oocytes retrievedd

    Measured: 36 hours after hCG administration

Secondary outcomes (3)

  1. Clinical pregnancy rate

    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.

    Measured: 6weeks

  2. ongoing pregnancy rate

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

    Measured: 12weeks

  3. Optimal number of embryo

    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

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2017
  2. Study start15 Nov 2017
  3. Primary completion18 Jun 2021
  4. Study completion18 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
552 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03300518
Sponsor's protocol ID
MSD-MISP-ZX-01
Status last verified
Jan 2022
First submitted
28 Sep 2017
Last updated
11 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35460400

Questions about this trial

What is this clinical trial studying?

A study testing Follitropin Beta;MSD, Ganirelix and hCG in people with Infertility, run by Reproductive & Genetic Hospital of CITIC-Xiangya at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of oocytes retrieved by the IVG 36 hours after hCG administration (time frame: 36 hours after hCG administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03300518, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.

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