Egg DonationPhase 4NCT02069808
Efficacy of Recombinant FSH/GnRH Antagonist Protocol With and Without LH Adjunct for Egg Bank Donation
A Phase 4 study testing Follistim, Ganirelix and Menotropins in people with Egg Donation, run by Michigan Reproductive Medicine at 1 site in United States.
Trial summary
Disprove the null hypothesis as follows: Among the investigator's egg bank donors undergoing ovulation induction with recombinant FSH medication per treatment protocol outlined below, use of adjunctive LH activity medication Menopur ™ , will result in the same number of mature oocytes recovered and cryopreserved as… Read more about this study
- Who is it for?
- Ages 18 to 28 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Egg Donation
- What is being tested?
- Follistim, Ganirelix and Menotropins
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 8 Mar 2017
- 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 28 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient selection: women volunteers in good health wishing to serve as egg donors who have satisfied all screening criteria for FDA and the Michigan Egg Bank: Age range 18-to 28 years. BMI 18 to 25. Resting antral follicle count of 16 or greater. Cycle day 3 FSH <10 mIU/ml. AMH >2.0 ng/ml.
Who cannot join
- Women who do not meet the inclusion criteria. Cigarette smokers. Fail random drug screening tests.
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan Reproductive Medicine
Bloomfield Hills, Michigan, 48304-5130
About this study
Official title: Efficacy of Recombinant FSH/GnRH Antagonist Protocol With and Without LH Adjunct and GnRH Agonist Trigger for Egg Bank Donation
Disprove the null hypothesis as follows:
Among the investigator's egg bank donors undergoing ovulation induction with recombinant FSH medication per treatment protocol outlined below, use of adjunctive LH activity medication Menopur ™ , will result in the same number of mature oocytes recovered and cryopreserved as from egg donors not treated with Menopur™.
Read more
Objectives:
Compare efficacy of recombinant FSH (Follistim ™) with and without adjunct LH activity medication Menopur ™ for our volunteer egg bank donors.
Efficacy defined as:
- #Days of ovarian stimulation to GnRH agonist trigger.
- Peak serum estradiol level on day of GnRH agonist trigger.
- Number of follicles >15 mm average diameter on day of GnRH agonist trigger.
- Number of mature oocytes recovered and cryopreserved.
Study type: Randomized prospective clinical trial.
Patient selection: Voluntary egg donors who have satisfied all screening criteria for FDA and the Michigan Egg Bank: Age range 18-to 39 years. BMI 18 to 25. Resting antral follicle count of 16 or greater. Cycle day 3 FSH <10 mIU/ml. AMH >2.0 ng/ml.
Study design:
Two groups- Group A- Recombinant FSH Follistim only; Group B- Recombinant FSH Follistim and adjunct Menopur. Both groups will use GnRH agonist trigger 36 hours prior to egg retrieval.
Random number generator with patients assigned basd on odd or even numbers.
Number of subjects: 25 in each group. Total of 50 subjects. This takes into account possible cycle cancellation for poor ovarian response or patient elective withdrawal to result in at least 20 subjects in each group completing the study.
Primary measure of outcome: number of mature oocytes recovered and cryopreserved.
Secondary measures of outcome:
- #Days of ovarian stimulation to GnRH agonist trigger.
- Peak serum estradiol level on day of GnRH agonist trigger.
- Number of follicles >15 mm average diameter on day of GnRH agonist trigger.
Read the detailed description
Background:
The investigator's Center has been studying human oocyte cryopreservation by vitrification since July 1, 2008 (Western Institutional Board Review -WIRB Pro. Nr: 20081080, WIRB Study Nr.: 1100421). The first phase of the investigator's study was to assess efficacy of oocyte cryopreservation among voluntary egg donors with end points for outcomes including rates of oocyte thaw survival, fertilization, embryo development, implantation, clinical pregnancy, live birth and infant health. The rationale for starting with egg donors was that they represent a population of women most likely to have optimal egg quality and a short turnaround time from vitrification to thaw, IVF and embryo transfer into an appropriate egg recipient patient. If the investigator could establish good outcomes when egg quality is optimal, then there would be good hope to provide reliable egg cryopreservation technology to women in need of fertility preservation when facing treatment of cancer; other illnesses for which treatments harm their eggs; women choosing personal egg banking and for women who wish to avoid excess embryo creation on moral or religious grounds.
The investigator's study observations were that outcomes with use of previously cryopreserved donor eggs was equivalent to fresh donor eggs: 90% of mature oocytes survived the thaw, 76% of thawed oocytes fertilized normally with ICSI, 98% of recipient women had a day 5 embryo transfer with one or two embryos transferred, implantation rate of 42%, 60% or recipient women achieved clinical pregnancy, 58% live birth rate and no birth defects have been observed in over 40 babies delivered through this technology at our Center.
In the beginning of 2012, we opened up the second phase of the investigator's study to include women in need of fertility preservation for the indications mentioned above. No outcomes are yet known due to the expected time deferment from oocyte cryopreservation to use. The favorable outcomes from donor egg bank IVF led to the investigator's establishing the Michigan Egg Bank. On October 22, 2012, the American Society for Reproductive Medicine announced a new practice guideline that oocyte cryopreservation technology should be considered mainstream medical therapy and no long be considered experimental medical care. The investigator's closed the WIRB study November, 26, 2012.
Rationale:
Ovarian stimulation for egg donation should be provided offering the safest and simplest process for our egg donors. Avoiding complications of ovarian hyperstimulation syndrome while assuring recruitment and harvest of good quality oocytes is a main goal in caring for the investigator's volunteer egg donors. Use of FSH medications with GnRH antagonist and GnRH agonist trigger is the protocol of choice for all of the investigator's egg donors. The investigator's egg donors have experienced no complications and rapid recovery. GnRH antagonists have been shown to suppress endogenous ovarian androgen synthesis. In using GnRH antagonist, adjunctive LH or low dose hCG combined with FSH medication has been a mainstream assumption to assure sufficient endogenous ovarian testosterone is present as a substrate for estrogen synthesis and normal folliculogenesis.
In an effort to improve patient compliance by simplifying the use of medications for the investigator's egg donors, the investigator wishes to examine the efficacy of recombinant FSH without additional separate medication of adjunct LH activity in the form Menopur ™.
- Conditions
- Egg Donation
- Being tested
- Follistim, Ganirelix, Menotropins, Leuprolide, Transvaginal ultrasound guided needle aspiration of oocytes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FollistimDrug
Also called Follistim AQ
Follicle stimulating hormone promotes recruitment of follicles for ovulation.
GanirelixDrug
Also called Ganirelix Acetate
GnRH antagonist preventing a problematic risk of premature LH surge during ovulation induction therapy.
MenotropinsDrug
Also called Menopur
Combination of follicle stimulating hormone and Luteinizing hormone activity promotes recruitment of follicles for ovulation. Absence or presence of this medication is the difference being tested between the two arms of the study.
LeuprolideDrug
Also called Lupron, Leuprolide acetate
Promotes endogenous LH surge signaling oocyte maturation followed by ovulation. This controls timing for oocyte collection.
Transvaginal ultrasound guided needle aspiration of oocytesProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group B: Follistim and Menopur | Experimental | Group B: N=25 subjects
1. Cycle day 2 start Follistim 200 U/day up to 11 days duration.
2. Cycle day 2 start Menopur (menotropins) 75 U/day up to 11 days duration.
3. Add GnRH antagonist Ganirelix 250 µg/day starting 5 days before GnRH agonist trigger.
4. GnRH agonist Leuprolide Acetate (Lupron) 1 mg subcutaneous injection 36 hours prior to egg collection.
5. Transvaginal ultrasound guided needle aspiration of oocytes 36 hours after Lupron trigger. Receives: Drug: Follistim; Drug: Ganirelix; Drug: Menotropins; Drug: Leuprolide; Procedure: Transvaginal ultrasound guided needle aspiration of oocytes |
| Group A: Follistim only | Active comparator | Group A: N=25 subjects
1. Cycle day 2 start Follistim 250 U/day up to 11 days duration.
2. Add GnRH antagonist Ganirelix 250 µg/day starting 5 days before GnRH agonist trigger.
3. GnRH agonist Leuprolide Acetate (Lupron) 1 mg subcutaneous injection 36 hours prior to egg collection.
4. Transvaginal ultrasound guided needle aspiration of oocytes 36 hours after Lupron trigger. Receives: Drug: Follistim; Drug: Ganirelix; Drug: Leuprolide; Procedure: Transvaginal ultrasound guided needle aspiration of oocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of mature oocytes recovered and cryopreserved.
Immediately after egg harvest, The embyrologist performed microscopic examination of oocytes and is able to determine if the oocyte has completed meiosis 1 with the extrusion of the first polar body and has entered the second stage of meiosis. An oocyte of this developmental stage is considered mature and receptive to a sperm.
Measured: 2 weeks
Secondary outcomes (3)
1) #Days of ovarian stimulation to GnRH agonist trigger.
Day 1 is the first day of menotropin therapy. The total number of days is counted from day 1 until the day of GnRH agonist trigger. This determines the total number of days subject is exposed to menotropin therapy.
Measured: 2 weeks
2) Peak serum estradiol level on day of GnRH agonist trigger
Serum estradiol level is tested in the day of GnRH agonist trigger.
Measured: 2 weeks
Number of follicles >15 mm average diameter on day of GnRH agonist trigger
Transvaginal utlrasound measures average diameter of ovarian follicles. Mature follicles have an average diameter of at least 15 mm or greater.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startApr 2014
- Primary completion12 Feb 2017
- Study completion8 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Egg DonationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan Reproductive Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael S. Mersol-Barg, MD, Michigan Reproductive Medicine
- Investigators
- Michael S Mersol-Barg, MD, Principal investigator, Michigan Reproductive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069808
- Sponsor's protocol ID
- MRM2014-1
- Status last verified
- Mar 2018
- First submitted
- 19 Feb 2014
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Recombinant FSH/GnRH Antagonist Protocol With and Without LH Adjunct and GnRH Agonist Trigger for Egg Bank Donation
- ClinicalTrials.gov ID
- NCT02069808
- Acronym / sponsor ID
- MRM2014-1
- Conditions
- Egg Donation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Michigan Reproductive MedicineUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 12 Feb 2017 (actual)
- Study completion
- 8 Mar 2017 (actual)
- First posted
- 24 Feb 2014 (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.
Disprove the null hypothesis as follows:
Among the investigator's egg bank donors undergoing ovulation induction with recombinant FSH medication per treatment protocol outlined below, use of adjunctive LH activity medication Menopur ™ , will result in the same number of mature oocytes recovered and cryopreserved as from egg donors not treated with Menopur™.
Objectives:
Compare efficacy of recombinant FSH (Follistim ™) with and without adjunct LH activity medication Menopur ™ for our volunteer egg bank donors.
Efficacy defined as:
- #Days of ovarian stimulation to GnRH agonist trigger.
- Peak serum estradiol level on day of GnRH agonist trigger.
- Number of follicles >15 mm average diameter on day of GnRH agonist trigger.
- Number of mature oocytes recovered and cryopreserved.
Study type: Randomized prospective clinical trial.
Patient selection: Voluntary egg donors who have satisfied all screening criteria for FDA and the Michigan Egg Bank: Age range 18-to 39 years. BMI 18 to 25. Resting antral follicle count of 16 or greater. Cycle day 3 FSH <10 mIU/ml. AMH >2.0 ng/ml.
Study design:
Two groups- Group A- Recombinant FSH Follistim only; Group B- Recombinant FSH Follistim and adjunct Menopur. Both groups will use GnRH agonist trigger 36 hours prior to egg retrieval.
Random number generator with patients assigned basd on odd or even numbers.
Number of subjects: 25 in each group. Total of 50 subjects. This takes into account possible cycle cancellation for poor ovarian response or patient elective withdrawal to result in at least 20 subjects in each group completing the study.
Primary measure of outcome: number of mature oocytes recovered and cryopreserved.
Secondary measures of outcome:
- #Days of ovarian stimulation to GnRH agonist trigger.
- Peak serum estradiol level on day of GnRH agonist trigger.
- Number of follicles >15 mm average diameter on day of GnRH agonist trigger.
Detailed description
Background:
The investigator's Center has been studying human oocyte cryopreservation by vitrification since July 1, 2008 (Western Institutional Board Review -WIRB Pro. Nr: 20081080, WIRB Study Nr.: 1100421). The first phase of the investigator's study was to assess efficacy of oocyte cryopreservation among voluntary egg donors with end points for outcomes including rates of oocyte thaw survival, fertilization, embryo development, implantation, clinical pregnancy, live birth and infant health. The rationale for starting with egg donors was that they represent a population of women most likely to have optimal egg quality and a short turnaround time from vitrification to thaw, IVF and embryo transfer into an appropriate egg recipient patient. If the investigator could establish good outcomes when egg quality is optimal, then there would be good hope to provide reliable egg cryopreservation technology to women in need of fertility preservation when facing treatment of cancer; other illnesses for which treatments harm their eggs; women choosing personal egg banking and for women who wish to avoid excess embryo creation on moral or religious grounds.
The investigator's study observations were that outcomes with use of previously cryopreserved donor eggs was equivalent to fresh donor eggs: 90% of mature oocytes survived the thaw, 76% of thawed oocytes fertilized normally with ICSI, 98% of recipient women had a day 5 embryo transfer with one or two embryos transferred, implantation rate of 42%, 60% or recipient women achieved clinical pregnancy, 58% live birth rate and no birth defects have been observed in over 40 babies delivered through this technology at our Center.
In the beginning of 2012, we opened up the second phase of the investigator's study to include women in need of fertility preservation for the indications mentioned above. No outcomes are yet known due to the expected time deferment from oocyte cryopreservation to use. The favorable outcomes from donor egg bank IVF led to the investigator's establishing the Michigan Egg Bank. On October 22, 2012, the American Society for Reproductive Medicine announced a new practice guideline that oocyte cryopreservation technology should be considered mainstream medical therapy and no long be considered experimental medical care. The investigator's closed the WIRB study November, 26, 2012.
Rationale:
Ovarian stimulation for egg donation should be provided offering the safest and simplest process for our egg donors. Avoiding complications of ovarian hyperstimulation syndrome while assuring recruitment and harvest of good quality oocytes is a main goal in caring for the investigator's volunteer egg donors. Use of FSH medications with GnRH antagonist and GnRH agonist trigger is the protocol of choice for all of the investigator's egg donors. The investigator's egg donors have experienced no complications and rapid recovery. GnRH antagonists have been shown to suppress endogenous ovarian androgen synthesis. In using GnRH antagonist, adjunctive LH or low dose hCG combined with FSH medication has been a mainstream assumption to assure sufficient endogenous ovarian testosterone is present as a substrate for estrogen synthesis and normal folliculogenesis.
In an effort to improve patient compliance by simplifying the use of medications for the investigator's egg donors, the investigator wishes to examine the efficacy of recombinant FSH without additional separate medication of adjunct LH activity in the form Menopur ™.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B: Follistim and Menopur | Experimental | Drug: Follistim, Drug: Ganirelix, Drug: Menotropins, Drug: Leuprolide, Procedure: Transvaginal ultrasound guided needle aspiration of oocytesGroup B: N=25 subjects 1. Cycle day 2 start Follistim 200 U/day up to 11 days duration. 2. Cycle day 2 start Menopur (menotropins) 75 U/day up to 11 days duration. 3. Add GnRH antagonist Ganirelix 250 µg/day starting 5 days before GnRH agonist trigger. 4. GnRH agonist Leuprolide Acetate (Lupron) 1 mg subcutaneous injection 36 hours prior to egg collection. 5. Transvaginal ultrasound guided needle aspiration of oocytes 36 hours after Lupron trigger. |
| Group A: Follistim only | Active comparator | Drug: Follistim, Drug: Ganirelix, Drug: Leuprolide, Procedure: Transvaginal ultrasound guided needle aspiration of oocytesGroup A: N=25 subjects 1. Cycle day 2 start Follistim 250 U/day up to 11 days duration. 2. Add GnRH antagonist Ganirelix 250 µg/day starting 5 days before GnRH agonist trigger. 3. GnRH agonist Leuprolide Acetate (Lupron) 1 mg subcutaneous injection 36 hours prior to egg collection. 4. Transvaginal ultrasound guided needle aspiration of oocytes 36 hours after Lupron trigger. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patient selection: women volunteers in good health wishing to serve as egg donors who have satisfied all screening criteria for FDA and the Michigan Egg Bank: Age range 18-to 28 years. BMI 18 to 25. Resting antral follicle count of 16 or greater. Cycle day 3 FSH <10 mIU/ml. AMH >2.0 ng/ml.
Key exclusion criteria (1 listed)
- Women who do not meet the inclusion criteria. Cigarette smokers. Fail random drug screening tests.
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 |
|---|---|---|
| FollistimAlso: Follistim AQFollicle stimulating hormone promotes recruitment of follicles for ovulation. | Drug | Group A: Follistim only, Group B: Follistim and Menopur |
| GanirelixAlso: Ganirelix AcetateGnRH antagonist preventing a problematic risk of premature LH surge during ovulation induction therapy. | Drug | Group A: Follistim only, Group B: Follistim and Menopur |
| MenotropinsAlso: MenopurCombination of follicle stimulating hormone and Luteinizing hormone activity promotes recruitment of follicles for ovulation. Absence or presence of this medication is the difference being tested between the two arms of the study. | Drug | Group B: Follistim and Menopur |
| LeuprolideAlso: Lupron, Leuprolide acetatePromotes endogenous LH surge signaling oocyte maturation followed by ovulation. This controls timing for oocyte collection. | Drug | Group A: Follistim only, Group B: Follistim and Menopur |
| Transvaginal ultrasound guided needle aspiration of oocytes | Procedure or surgery | Group A: Follistim only, Group B: Follistim and Menopur |
Primary outcome
number of mature oocytes recovered and cryopreserved.
Time frame: 2 weeks
Immediately after egg harvest, The embyrologist performed microscopic examination of oocytes and is able to determine if the oocyte has completed meiosis 1 with the extrusion of the first polar body and has entered the second stage of meiosis. An oocyte of this developmental stage is considered mature and receptive to a sperm.
3 secondary outcomes
1) #Days of ovarian stimulation to GnRH agonist trigger.
Time frame: 2 weeks
2) Peak serum estradiol level on day of GnRH agonist trigger
Time frame: 2 weeks
Number of follicles >15 mm average diameter on day of GnRH agonist trigger
Time frame: 2 weeks
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 23 Mar 2018.
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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 S Mersol-Barg, MD principal investigator
Michigan Reproductive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Follistim, Ganirelix and Menotropins in people with Egg Donation, run by Michigan Reproductive Medicine 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 1 inclusion and 1 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 23 Mar 2018. 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.
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 recovered and cryopreserved. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2018.