FertilityNCT01669291
Effect of GnRH Antagonist vs Agonist Long on IVF Outcome, Peak Estradiol Level,and Duration of Stimulation
A study testing Bravelle and Menopur, Agonist and Antagonist in people with Fertility, run by Main Line Fertility Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if utilizing GnRH antagonists versus agonist long protocol during controlled ovarian stimulation (COH) with human-derived gonadotropins for assisted reproduction affects IVF outcome, peak estradiol level, and duration of stimulation. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility
- What is being tested?
- Bravelle and Menopur, Agonist and Antagonist
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to May 2014
- 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 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 21-40 (inclusive up to 41)
- Day 2-4 FSH < or equal to 10
- Antimullerian Hormone (AMH) greater than or equal to 1.0
- Between 5 and 20 antral follicles on day 2-4
- Body Mass Index (BMI)>or equal to 18 and < or equal to 32
Who cannot join
- Smokers
- Polycystic Ovarian Disease
- Endometriosis greater than Stage I
- Testicular aspirated sperm
Trial locations and contacts
1 site in 1 country.
United States1 site
Main Line Fertility Center
Bryn Mawr, Pennsylvania, 19010
About this study
Official title: Effect of GnRH Antagonist Protocol vs Agonist Long Protocol During Controlled Hyperstimulation (COH)for Assisted Reproduction on IVF Outcome, Peak Estradiol Level, and Duration of Stimulation.
The purpose of this study is to determine if utilizing GnRH antagonists versus agonist long protocol during controlled ovarian stimulation (COH) with human-derived gonadotropins for assisted reproduction affects IVF outcome, peak estradiol level, and duration of stimulation.
Read the detailed description
No detailed description
- Conditions
- Fertility
- Being tested
- Bravelle and Menopur, Agonist, Antagonist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bravelle and MenopurDrug
Bravelle and Menopur are used for controlled ovarian stimulation (COH)
AgonistDrug
Also called Leuprolide Acetate, Lupron
Agonist (Lupron) is used to suppress endogenous pituitary LH for the premature LH surges.
AntagonistDrug
Also called ganirelix acetate, cetrorelix acetate
Ganirelix acetate or cetrorelix acetate Agonist is used to suppress endogenous pituitary LH for the premature LH surges.
| Study group | Role | What they receive |
|---|---|---|
| Bravelle & Menopur Agonist Long Protocol | Active comparator | Patients will use an LH agonist (Lupron) starting on day 18 of the oral contraceptive pill (OCP), 5 units b.i.d. followed by 5 units q.d. beginning on day one of stimulation medications. The 5 units q.d. dose will continue until the day of hCG administration.Patients will administer Bravelle and Menopur for ovarian stimulation. Receives: Drug: Bravelle and Menopur; Drug: Agonist |
| Bravelle & Menopur Antagonist Protocol | Active comparator | Patients will complete standard dose of oral contraceptive pill (OCP) and will then administer GnRH antagonist (ganirelix acetate or cetrorelix acetate) 0.25 mg q.d. during the stimulation phase when the lead follicle size reaches 12mm. The antagonist will continue until the day of hCG administration. Patients will administer Bravelle and Menopur for ovarian stimulation. Receives: Drug: Bravelle and Menopur; Drug: Antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if COH in IVF patients using Bravelle & Menopur with antagonists results in improved or equal IVF results compared to patients using agonist.
Measured: One year
Secondary outcomes (2)
To determined if COH in IVF patients using Bravelle & Menopur with antagonists results in lower peak estradiol levels compared to agonist
Measured: One year
To determine if COH patients using Bravelle & Menopur with antagonist antagonists results inn shorter period of stimulation compared with agonist.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for FertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Main Line Fertility Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Michael J Glassner, M.D., Principal investigator, Main Line Fertility CenterSharon H. Anderson, Ph.D, Study director, Main Line Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669291
- Sponsor's protocol ID
- MLFC-003
- Status last verified
- Jun 2014
- First submitted
- 9 Aug 2012
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ludwig, Michael. GnRH antagonists. Textbook of Assisted Reproductive Technologies - Laboratory and Clinical Perspectives. Third edition. Edited by Gardner, D, Weissman, A, Howles, C, Shoham, Z. 2009: 539-552.
Ludwig M, Katalinic A, Diedrich K. Use of GnRH antagonists in ovarian stimulation for assisted reproductive technologies compared to the long protocol. Meta-analysis. Arch Gynecol Obstet. 2001 Nov;265(4):175-82. doi: 10.1007/s00404-001-0267-2.
PubMed 11789740Fluker M, Grifo J, Leader A, Levy M, Meldrum D, Muasher SJ, Rinehart J, Rosenwaks Z, Scott RT Jr, Schoolcraft W, Shapiro DB; North American Ganirelix Study Group. Efficacy and safety of ganirelix acetate versus leuprolide acetate in women undergoing controlled ovarian hyperstimulation. Fertil Steril. 2001 Jan;75(1):38-45. doi: 10.1016/s0015-0282(00)01638-1.
PubMed 11163814Ludwig M, Felberbaum RE, Devroey P, Albano C, Riethmuller-Winzen H, Schuler A, Engel W, Diedrich K. Significant reduction of the incidence of ovarian hyperstimulation syndrome (OHSS) by using the LHRH antagonist Cetrorelix (Cetrotide) in controlled ovarian stimulation for assisted reproduction. Arch Gynecol Obstet. 2000 Jul;264(1):29-32. doi: 10.1007/pl00007479.
PubMed 10985616
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of GnRH Antagonist Protocol vs Agonist Long Protocol During Controlled Hyperstimulation (COH)for Assisted Reproduction on IVF Outcome, Peak Estradiol Level, and Duration of Stimulation.
- ClinicalTrials.gov ID
- NCT01669291
- Acronym / sponsor ID
- MLFC-003
- Conditions
- Fertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Main Line Fertility CenterUniversity, hospital or other
- Collaborators
- Ferring Pharmaceuticals
- Study start
- Jul 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 21 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if utilizing GnRH antagonists versus agonist long protocol during controlled ovarian stimulation (COH) with human-derived gonadotropins for assisted reproduction affects IVF outcome, peak estradiol level, and duration of stimulation.
Detailed description
No detailed description
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bravelle & Menopur Agonist Long Protocol | Active comparator | Drug: Bravelle and Menopur, Drug: AgonistPatients will use an LH agonist (Lupron) starting on day 18 of the oral contraceptive pill (OCP), 5 units b.i.d. followed by 5 units q.d. beginning on day one of stimulation medications. The 5 units q.d. dose will continue until the day of hCG administration.Patients will administer Bravelle and Menopur for ovarian stimulation. |
| Bravelle & Menopur Antagonist Protocol | Active comparator | Drug: Bravelle and Menopur, Drug: AntagonistPatients will complete standard dose of oral contraceptive pill (OCP) and will then administer GnRH antagonist (ganirelix acetate or cetrorelix acetate) 0.25 mg q.d. during the stimulation phase when the lead follicle size reaches 12mm. The antagonist will continue until the day of hCG administration. Patients will administer Bravelle and Menopur for ovarian stimulation. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ages 21-40 (inclusive up to 41)
- Day 2-4 FSH < or equal to 10
- Antimullerian Hormone (AMH) greater than or equal to 1.0
- Between 5 and 20 antral follicles on day 2-4
- Body Mass Index (BMI)>or equal to 18 and < or equal to 32
Key exclusion criteria (4 listed)
- Smokers
- Polycystic Ovarian Disease
- Endometriosis greater than Stage I
- Testicular aspirated sperm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bravelle and MenopurBravelle and Menopur are used for controlled ovarian stimulation (COH) | Drug | Bravelle & Menopur Agonist Long Protocol, Bravelle & Menopur Antagonist Protocol |
| AgonistAlso: Leuprolide Acetate, LupronAgonist (Lupron) is used to suppress endogenous pituitary LH for the premature LH surges. | Drug | Bravelle & Menopur Agonist Long Protocol |
| AntagonistAlso: ganirelix acetate, cetrorelix acetateGanirelix acetate or cetrorelix acetate Agonist is used to suppress endogenous pituitary LH for the premature LH surges. | Drug | Bravelle & Menopur Antagonist Protocol |
Primary outcome
To determine if COH in IVF patients using Bravelle & Menopur with antagonists results in improved or equal IVF results compared to patients using agonist.
Time frame: One year
2 secondary outcomes
To determined if COH in IVF patients using Bravelle & Menopur with antagonists results in lower peak estradiol levels compared to agonist
Time frame: One year
To determine if COH patients using Bravelle & Menopur with antagonist antagonists results inn shorter period of stimulation compared with agonist.
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
- BackgroundLudwig, Michael. GnRH antagonists. Textbook of Assisted Reproductive Technologies - Laboratory and Clinical Perspectives. Third edition. Edited by Gardner, D, Weissman, A, Howles, C, Shoham, Z. 2009: 539-552.
- Background: PubMed 11789740Ludwig M, Katalinic A, Diedrich K. Use of GnRH antagonists in ovarian stimulation for assisted reproductive technologies compared to the long protocol. Meta-analysis. Arch Gynecol Obstet. 2001 Nov;265(4):175-82. doi: 10.1007/s00404-001-0267-2.
- Background: PubMed 11163814Fluker M, Grifo J, Leader A, Levy M, Meldrum D, Muasher SJ, Rinehart J, Rosenwaks Z, Scott RT Jr, Schoolcraft W, Shapiro DB; North American Ganirelix Study Group. Efficacy and safety of ganirelix acetate versus leuprolide acetate in women undergoing controlled ovarian hyperstimulation. Fertil Steril. 2001 Jan;75(1):38-45. doi: 10.1016/s0015-0282(00)01638-1.
- Background: PubMed 10985616Ludwig M, Felberbaum RE, Devroey P, Albano C, Riethmuller-Winzen H, Schuler A, Engel W, Diedrich K. Significant reduction of the incidence of ovarian hyperstimulation syndrome (OHSS) by using the LHRH antagonist Cetrorelix (Cetrotide) in controlled ovarian stimulation for assisted reproduction. Arch Gynecol Obstet. 2000 Jul;264(1):29-32. doi: 10.1007/pl00007479.
Related trials for Fertility
Not yet recruiting
Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Diminished Ovarian Reserve
Diminished Ovarian Reserve (DOR)
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
Active, not recruiting
Ovarian Tissue Cryopreservation in Children
Cancer
Not yet recruitingObservational study
Perceptions and Acceptance of Grafting of Cryopreserved Testicular Tissue
Fertility, Testicular Tissue Cryopreserved
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Glassner, M.D. principal investigator
Main Line Fertility Center
Sharon H. Anderson, Ph.D study director
Main Line Fertility Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bravelle and Menopur, Agonist and Antagonist in people with Fertility, run by Main Line Fertility Center at 1 site in United States.
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 5 inclusion and 4 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 4 Jun 2014. 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 United States. 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?
To determine if COH in IVF patients using Bravelle & Menopur with antagonists results in improved or equal IVF results compared to patients using agonist. (time frame: One year). 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 NCT01669291, which also lists 4 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 4 Jun 2014.