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InfertilityPhase 4NCT02703584

Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation

A Phase 4 study testing Buseralin and pregnyl in people with Infertility, run by Mount Sinai Hospital, Canada at 1 site in Canada.

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

All the studies, demonstrating improved oocyte maturity and high pregnancy rate with the dual trigger are all retrospective. The investigators therefore aim to perform a prospective randomized controlled study in normal responders, comparing cycles triggered with hCG to those triggered with hCG+GnRH agonist. Read more about this study

Who is it for?
Ages 18 to 41 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility
What is being tested?
Buseralin and pregnyl
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
276 participants
Where
1 siteCanada
Study dates
Mar 2016to Sep 2018
Phase
Phase 4
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 18 to 41 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Women during one of their first 3 IVF cycle attempts
  • Women between the ages of 18-42.
  • BMI (body mass index) of 18-35.
  • AMH (Anti mullerian hormone) > 1 ng/ml
  • FSH˂ 20 IU/L.
  • Informed consent.

Who cannot join

  • Women with low ovarian response
  • Previous enrollment in this study.
  • AFC>20
  • E2 above 15,000 pmol/l at the trigger day.
  • hypersensitive to Suprefact/Pregny/gonal F/Purigon/Menopur/progesterone, and/or their ingredients/components of the formulation
  • primary ovarian failure
Show all 19Show fewer
  • pregnancy and breast-feeding
  • active blood clots
  • undiagnosed uterine or genital bleeding
  • endometriosis
  • uncontrolled hypertension;
  • uncontrolled diabetes
  • abnormal liver and kidney functions
  • abnormal ECG, e.g. QT prolongation and torsades de pointes
  • cancers/tumors, e.g. pituitary adenomas, ovarian cysts, etc.
  • HIV, HBV and HCV infections
  • low bone mineral density (BMD) and an increased risk of bone fracture, such as chronic alcohol and/or tobacco use, presumed or strong family history of osteoporosis or chronic use of drugs that can reduce bone mass such as anticonvulsants or corticosteroids
  • suicidal tendency, history or disposition to seizures, state of confusion, clinically relevant psychiatric disorders, and brain lesions
  • Use of an investigational drug or participation in an investigational study within 30 days prior to this study.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • TRIO Fertility

    Toronto, Ontario, M5G 2K4

Other trials in Canada

About this study

Official title: Co Administration of GnRH Agonist and hCG for Final Oocyte Maturation- A Randomized Controlled Trial

All the studies, demonstrating improved oocyte maturity and high pregnancy rate with the dual trigger are all retrospective. The investigators therefore aim to perform a prospective randomized controlled study in normal responders, comparing cycles triggered with hCG to those triggered with hCG+GnRH agonist.

Read the detailed description

A prospective, randomized, double blinded clinical trial. Patients will undergo standard clinical and hormonal investigation as usual for IVF. Patients that will be given the standard GnRH antagonist IVF protocol will be prospectively randomized into two groups: 1. hCG group- will be triggered for final follicular maturation with hCG (Pregnyl 10,000IU) as is usual and placebo (normal saline) - 36 hours prior to oocyte aspiration. 2. The Double trigger group- will receive GnRH agonist (Suprefact 0.5 mg) and hCG (Pregnyl 10,000IU) 36 hours prior to the oocyte aspiration. All patients will be supplemented with the usual progesterone preparation (vaginal progesterone suppositories) for luteal support.

In order to increase the rate of MII from to 65% to 80% with an alpha error of 5% and beta error of 80% the sample size needed is 276 total patients in both groups or 138 patients in each group.

Conditions
Infertility
Being tested
Buseralin, Placebo, pregnyl
Keywords
Double trigger
Medical subject headings
Infertility

What participants receive

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

  • BuseralinDrug

    Also called Suprefact

  • PlaceboOther

    Also called normal saline

  • pregnylDrug

    Also called hCG

Study groups in NCT02703584
Study groupRoleWhat they receive
Double triggerExperimentalTriggering of ovulation with GnRH agonist ( Suprefact 0.5mg) + hCG ( Pregnyl 10,000IU)
Receives: Drug: Buseralin; Drug: pregnyl
controlPlacebo comparatorTriggering of ovulation with hCH ( Pregnyl 10,000IU) + Placebo
Receives: Other: Placebo; Drug: pregnyl

What is being measured

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

  1. Number of mature oocytes

    We will gather the information regarding the number of mature oocytes 2 days after the triggering- ( randomization)

    Measured: 2 days after randomization

Secondary outcomes (1)

  1. Blastocyst rate

    Measured: 8 days after the randomization

Timeline

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

  1. First posted9 Mar 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionSep 2018
  4. Study completionSep 2018

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
276 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02703584
Sponsor's protocol ID
03012016
Status last verified
Jun 2016
First submitted
3 Mar 2016
Last updated
28 Apr 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Ozelci R, Yenigul NN, Dilbaz S, Dilbaz B, Aldemir O, Kaplanoglu I, Gucel F, Baser E, Tekin OM. The Association of ICSI Outcomes with Semen and Blood Bisphenol A Concentrations of the Male Partner. Reprod Sci. 2024 May;31(5):1323-1331. doi: 10.1007/s43032-023-01446-y. Epub 2024 Jan 11.

    PubMed 38212582

  • Haas J, Bassil R, Samara N, Zilberberg E, Mehta C, Orvieto R, Casper RF. GnRH agonist and hCG (dual trigger) versus hCG trigger for final follicular maturation: a double-blinded, randomized controlled study. Hum Reprod. 2020 Jul 1;35(7):1648-1654. doi: 10.1093/humrep/deaa107.

    PubMed 32563188

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Buseralin and pregnyl in people with Infertility, run by Mount Sinai Hospital, Canada at 1 site in Canada.

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 6 inclusion and 19 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 28 Apr 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Number of mature oocytes (time frame: 2 days after randomization). 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 NCT02703584, which also lists 2 linked publications.

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 28 Apr 2022.

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