Trial · Interventional

Status unknownPhase 4Registry data

Efficacy and Safety of Medication Used to Stimulate Ovulation

NCTNCT02715336Other idCFC-01

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 666 participants (estimated)
Sponsor: Create Fertility Center · Other
Design: Randomized · Double masking
Countries: 1 country
Canada
Start: Oct 2015
Primary completion: Sept 2020 (estimated)
Completion: Sept 2021 (estimated)
First posted: 22 Mar 2016 (estimated)
Last update posted: 20 Jul 2020
Conditions: IVF Cycle · Ovarian Stimulation · Egg Retrieval · Pregnancy · Miscarriages · Ovarian Hyperstimulation

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2016201820202022

Ph 4
Efficacy and Safety of Medication Used to Stimulate Ovulation
NCT02715336
Oct 2015 to est. Sept 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Individuals undergoing In Vitro Fertilization must undergo controlled ovarian hyperstimulation (COH) to produce enough quality eggs for fertility treatment. Ovarian follicular responsiveness to COH with gonadotropins is extremely variable between patients and even from cycle to cycle for the same patient. Achieving an ideal follicular response is critical to the success of assisted reproduction treatment (ART). Patients have been classified as 'poor', 'normal' or 'high' responders, which dictate the amount of gonadotropins that they receive. It is still important to develop treatments with high efficacy, lower multiple birth rates, and a lower complication rate for each of these groups. In an era of evidence-based medicine and with special emphasis on reducing IVF risks (mainly OHSS and pregnancies with multiples), it is very important to find optimal and safe ovulation induction and triggering regimens for each patient population. The use of GnRH agonist (GnRHa) triggering among high responders in order to reduce or eliminate OHSS is an example of an important breakthrough in the clinical management of IVF patients. Although GnRHa triggering was shown to be as effective as human chorionic gonadotropin (hCG) at inducing oocyte maturation more than 20 years ago, its use to trigger ovulation was not possible until the introduction of GnRH antagonists for pituitary suppression. Another prominent trend in ART in recent years has been the introduction of dual triggering, which involves a combination of GnRHa plus hCG for triggering. This regimen creates simultaneous lutenizing hormone (LH) and follicle stimulating hormone (FSH) surges by the GnRHa, which resembles physiologic ovulation triggering, together with sustained LH-like activity from the hCG, which stimulates the corpus luteum to excrete sufficient hormonal endometrial support. Since its introduction, dual triggering has been gaining popularity due to outstanding results in retrospective studies among both normal and high responders. Moreover, in spite of the encouraging retrospective reports, prospective randomized controlled trials (RCT) on dual triggering have not been reported to date. The aim of the current proposed study is to compare the efficacy of dual triggering and conventional triggering among the three IVF populations (high, normal and poor responders).

Interventions

Ovulation induction with hCG and Lupron (GnRH agonist)Drug

Arms6

Experimental
Study group: High Responders
1000 units hCG
No intervention
Control group: High Responders
1000 units hCG
Experimental
Study group: Normal Responders
5000 units hCG
No intervention
Control group: Normal Responders
5000 units hCG
Experimental
Study group: Low Responders
10000 units hCG
No intervention
Control group: Low Responders
10000 units hCG

Primary outcomes6

Outcomes the sponsor listed as primary.

Implantation rate
Time frame · 14 days post IVF procedure
Human Chorionic Gonadotropin serum levels
Time frame · 2-4 weeks post IVF procedure
Ongoing pregnancy rate
Time frame · 9 months post IVF procedure
Miscarriage rate
Time frame · 9 months post procedure
Ovarian hyperstimulation syndrome
Time frame · 7 days post IVF procedure
Registry description
Mild OHSS: 1. Grade 1: Abdominal distention, Ovaries \<6 cm 2. Grade 2: Abdominal distention and nausea, vomiting and diarrhea, Ovaries \<6 cm Moderate OHSS: a) Grade 3: Grade II criteria and ultrasound ascites/weight gain, Ovaries 6-12 cm Severe OHSS: 1. Grade 4: Ascites/hydrothorax, Ovaries \>12 cm 2. Grade 5: Ascites/hydrothorax and hypovolemia, hemoconcentration, coagulation disorder, oliguria, shock, Ovaries \>12 cm
Fetal heartbeat measured by ultrasound
Time frame · 2-4 weeks post IVF procedure

Secondary outcomes(5)

Number of retrieved oocytes
Time frame · 5 days post IVF procedure
Number of retrieved Meiosis II oocytes
Time frame · 5 days post IVF procedure
Fertilization rate
Time frame · 5 days post IVF procedure
Number of Day 3 embryos/eggs retrieved
Time frame · 5 days post IVF procedure
Number of blastocysts/eggs retrieved
Time frame · 5 days post IVF procedure

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Observational study · 2013

4 results

Dual trigger with combination of gonadotropin-releasing hormone agonist and human chorionic gonadotropin significantly improves the live-birth rate for normal responders in GnRH-antagonist cycles.

Lin et al. 2013Fertility and sterilitycited by 110

PMID 23993928DOI 10.1016/j.fertnstert.2013.07.1976PUB-23993928

Full text at the publisher4 results

Publisher page See results (4)

Indexing hint: Randomized controlled trial · 2009

4 results

GnRH agonist versus recombinant HCG in an oocyte donation programme: a randomized, prospective, controlled, assessor-blind study.

Melo et al. 2009Reproductive biomedicine onlinecited by 86

PMID 19909588DOI 10.1016/j.rbmo.2009.06.001PUB-19909588

Rights unknown4 results

Source link See results (4)

Indexing hint: Randomized controlled trial · 2005

6 results

A lower ongoing pregnancy rate can be expected when GnRH agonist is used for triggering final oocyte maturation instead of HCG in patients undergoing IVF with GnRH antagonists.

Kolibianakis et al. 2005Human reproduction (Oxford, England)cited by 230

PMID 15979994DOI 10.1093/humrep/dei150PUB-15979994

Rights unknown6 results

Source link See results (6)

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2002

Endocrine profiles after triggering of final oocyte maturation with GnRH agonist after cotreatment with the GnRH antagonist ganirelix during ovarian hyperstimulation for in vitro fertilization.

Fauser et al. 2002The Journal of clinical endocrinology and metabolismcited by 225

PMID 11836309DOI 10.1210/jcem.87.2.8197PUB-11836309

Full text at the publisher

Publisher page

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 45 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

A) Dual triggering vs. GnRH agonist alone in high responders IVF patients Inclusion Criteria - At least one of the following risk factors: * AMH \> 29 pmol/L * AFC \> 16 * PCOS diagnosed according to Rotterdam criteria: any two of the following three features: 1) oligo- or anovulation; 2) clinical and/or biochemical hyper-androgenemia; and 3) PCO-US with exclusion of other etiologies as mentioned in the National Institute of Child Health and Human Development (NICHD) criteria * Previous OHSS * Previous cycle cancellation due to OHSS risk * Previous coasting * Participants initially recruited to the normal responders study who exhibit excessive ovarian response markers on triggering day: high amount of middle-large follicles (\> 13 follicles ≥ 11mm on triggering day). All previous inclusion criteria are assessed before initiation of the IVF cycle and ovarian stimulation, and all of them represent pre-stimulation risk factors for high ovarian response. The patient's actual response will be assessed on triggering day (after completion of ovarian stimulation). Final assignment of responder category followed by randomization will only be performed on the day of triggering * informed consent obtained * Must be 18 years or older * Ability to speak and read English, or understand French, Mandarin, Cantonese, Arabic, or Filipino. Exclusion criteria: * Chronic disease * Hypogonadotrophic hypogonadism * Untreated uterine abnormalities * E2\>4000 pg/ml (\>14,680 pmol/L) on trigger day. These very high risk patients will undergo GnRHa only trigger and will be excluded from the trial. B) Dual triggering vs. 5000 units hCG in normal responders Inclusion criteria: * Age above 18 years and less than 40 years * Do not fulfill criteria for poor responder or high responder Exclusion criteria: * Bologna criteria for poor responders exclusion: two of the following should need to be fulfilled: 1. Age \> 40 or other risk factor for decreased ovarian reserve (ex. ovarian surgery) 2. Single abnormal test for ovarian reserve (AFC \< 6 or AMH \< 8 pmol/L) 3. Previous poor response in previous cycle: cancellation or \< 4 retrieved oocytes in response to daily 150 FSH units * Criteria for high responders' exclusion 1. AMH \> 29 pmol/L 2. AFC \> 16 3. PCOS diagnosed according to Rotterdam criteria \[19, 28\]: any two of the following three features: 1) oligo- or anovulation; 2) clinical and/or biochemical hyper-androgenemia; and 3) PCO-US with exclusion of other etiologies as mentioned in the NICHD criteria 4. Previous OHSS 5. Previous cycle cancellation due to OHSS risk 6. Previous coasting 7. Excessive ovarian response markers on triggering day such as high amount of middle-large follicles (\> 13 follicles ≥ 11mm on triggering day) and E2 concentration (optional E2 \> 14500 pmol/L on triggering day). These patients will be allocated to the high responders group. * Untreated uterine abnormalities * Chronic disease C) Dual Triggering for Poor Responders Inclusion criteria: According to Bologna criteria two of the following should be fulfilled: * Age \> 40 or other risk factor for decreased ovarian reserve (ex. ovarian surgery). * Single abnormal test for ovarian reserve (AFC \< 6 or AMH \< 8 pmol/L). * Previous poor response in previous cycle: cancellation or \< 4 retrieved oocytes in response to daily 150 FSH units. Exclusion criteria: * Chronic disease * Untreated uterine abnormalities * Response consistent with normal or high responder, as defined above

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