AnovulationPhase 4NCT01250821
Gonadotrophin Dosage Using a Threshold Nomogram for Ovulation Induction in WHO Group II Anovulatory Infertility
A Phase 4 study testing Menopur in people with Anovulation and Infertility, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Ovulation disorders are a common cause of infertility in women. Most of these women can be classified as World Health Organization (WHO) Group II anovulatory patients as they have irregular or absent menstrual cycles but normal serum concentrations of follicle stimulation hormone (FSH) and estradiol. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Anovulation, Infertility
- What is being tested?
- Menopur
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2010to Apr 2013
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Anovulatory infertility
- Age 18 - 39 years
- Anovulation with oligomenorrhoea (> 35 days of mean cycle length) or amenorrhoea
- Normal serum FSH (< 10 IU/l)
- Two ovaries
- BMI < 35
Show all 9Show fewer
- First FSH/HMG cycle at the Fertility clinic.
- A sperm sample compatible with conception or semen from a donor.
- Tubal patency documented by either hysterosalpingography (HSG) or hysterosalpingography by ultrasound (HSU) in cases where the woman has had a pelvic infection or pelvic surgery.
Who cannot join
- A history of >12 ovulation induction cycles without achieving pregnancy.
- More than three earlier gonadotropin cycles at other clinics or earlier treatments with threshold doses below 75.
- Known hyperprolactinaemia or any other endocrine disturbance or systemic disease of the pituitary gland, thyroid gland, adrenal gland, pancreas, liver or kidney.
- Undiagnosed vaginal bleeding.
- Acute or chronic infection with HIV or hepatitis.
- Persistent ovarian cysts or endometriomas detected by ultrasound.
Show all 12Show fewer
- Tumors of the hypothalamus, pituitary gland, breast, adrenal gland or ovary.
- Pregnancy or lactation.
- Current or past alcohol or drug abuse.
- A history of chemo- or radiotherapy.
- Malformations of reproductive organs incompatible with pregnancy.
- Hypersensitivity to any trial medication.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Fertility Clinic, Section 4071, Rigshospitalet
Copenhagen, DK-2100
About this study
Ovulation disorders are a common cause of infertility in women. Most of these women can be classified as World Health Organization (WHO) Group II anovulatory patients as they have irregular or absent menstrual cycles but normal serum concentrations of follicle stimulation hormone (FSH) and estradiol.
The purpose of this study is to optimize the low-dose-step-up protocol traditionally used for ovulation induction with follicle-stimulating hormone (FSH) in women with anovulatory infertility WHO Group II.
Read more
Previous studies have established that menstrual cycle history, mean ovarian volume and BMI are significant predictors of FSH threshold dose in women with anovulatory infertility WHO Group II undergoing ovulation induction (Nyboe Andersen et al., 2008). A FSH dosage nomogram has been constructed based on these variables.
The aim of this study is to evaluate the clinical use of the nomogram in order to test the use of the variables to determine whether an individualized starting dose of FSH can be used for ovulation induction in anovulatory patients.
It is the hypothesis that an individualized starting dose of gonadotrophin will minimize the disadvantages of the treatment and that the stimulation period of the individualized nomogram-based treatment will be 25% shorter than observed in the standard protocol.
The primary endpoint is the proportion of patients who reach the criteria for hCG-administration within 14 days of Menopur stimulation. The results of the study will be compared with the data obtained in the Menopur Ovulation Induction Trial (Platteau et al., 2006).
- Conditions
- Anovulation, Infertility
- Being tested
- Menopur
- Keywords
- Infertility, Anovulation, Ovulation induction
- Medical subject headings
- Anovulation, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenopurDrug
The medication used in this study is the follicle-stimulating hormone "highly purified human menopausal gonadotrophin" (HP-HMG), Menopur, (Ferring a/s).
Stimulation with HP-hMG (Menopur) is started on day 2-5 of menstrual bleeding.The HP-hMG starting dose is calculated based on the nomogram predicting the threshold dose. The dose-range is from 75 IU/day to 187.5 IU/day.
| Study group | Role | What they receive |
|---|---|---|
| Ovulation induction | Experimental | Not described Receives: Drug: Menopur |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who reach the criteria for hCG-administration within 14 days of FSH stimulation.
The HCG-criteria is defined as:
- One follicle with a diameter of >17 mm or two or three follicles > 15 mm (verified by transvaginal ultrasound).
- HCG should not be given if there is no response after 35 days or > 4 follicles > 15 mm (unless converted to IVF/ICSI).
- If a patient is seen with one to three follicles of 15 - 16 mms HCG can be administered on the same or on the next day due to a presumed growth of follicles of + 2 mm/day.
Measured: 14 days of FSH stimulation
Secondary outcomes (1)
Endocrinological characteristics and follicular dynamics of anovulatory infertility WHO Group II
Prediction of FSH response in anovulatory infertility WHO Group II based on endocrinology, sonography, FSH-receptor status and demography
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnovulationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Holbaek Sygehus
- Responsible party
- Principal investigator, Mette Petri Lauritsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Mette P Lauritsen, MD, Principal investigator, Copenhagen University Hospital, RigshospitaletAnders N Andersen, Prof. MD, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250821
- Sponsor's protocol ID
- 2010-021459-16
- Status last verified
- Apr 2013
- First submitted
- 30 Nov 2010
- Last updated
- 19 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nyboe Andersen A, Balen A, Platteau P, Devroey P, Helmgaard L, Arce JC; Bravelle Ovulation Induction (BOI) Study Group. Predicting the FSH threshold dose in women with WHO Group II anovulatory infertility failing to ovulate or conceive on clomiphene citrate. Hum Reprod. 2008 Jun;23(6):1424-30. doi: 10.1093/humrep/den089. Epub 2008 Mar 26.
PubMed 18372254Platteau P, Andersen AN, Balen A, Devroey P, Sorensen P, Helmgaard L, Arce JC; Menopur Ovulation Induction (MOI) Study Group. Similar ovulation rates, but different follicular development with highly purified menotrophin compared with recombinant FSH in WHO Group II anovulatory infertility: a randomized controlled study. Hum Reprod. 2006 Jul;21(7):1798-804. doi: 10.1093/humrep/del085. Epub 2006 Mar 29.
PubMed 16571641
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gonadotrophin Dosage Using a Threshold Nomogram for Ovulation Induction in WHO Group II Anovulatory Infertility
- ClinicalTrials.gov ID
- NCT01250821
- Acronym / sponsor ID
- 2010-021459-16
- Conditions
- Anovulation, Infertility
- Keywords
- Infertility, Anovulation, Ovulation induction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Holbaek Sygehus
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 1 Dec 2010 (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.
Ovulation disorders are a common cause of infertility in women. Most of these women can be classified as World Health Organization (WHO) Group II anovulatory patients as they have irregular or absent menstrual cycles but normal serum concentrations of follicle stimulation hormone (FSH) and estradiol.
The purpose of this study is to optimize the low-dose-step-up protocol traditionally used for ovulation induction with follicle-stimulating hormone (FSH) in women with anovulatory infertility WHO Group II.
Previous studies have established that menstrual cycle history, mean ovarian volume and BMI are significant predictors of FSH threshold dose in women with anovulatory infertility WHO Group II undergoing ovulation induction (Nyboe Andersen et al., 2008). A FSH dosage nomogram has been constructed based on these variables.
The aim of this study is to evaluate the clinical use of the nomogram in order to test the use of the variables to determine whether an individualized starting dose of FSH can be used for ovulation induction in anovulatory patients.
It is the hypothesis that an individualized starting dose of gonadotrophin will minimize the disadvantages of the treatment and that the stimulation period of the individualized nomogram-based treatment will be 25% shorter than observed in the standard protocol.
The primary endpoint is the proportion of patients who reach the criteria for hCG-administration within 14 days of Menopur stimulation. The results of the study will be compared with the data obtained in the Menopur Ovulation Induction Trial (Platteau et al., 2006).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovulation induction | Experimental | Drug: Menopur |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Anovulatory infertility
- Age 18 - 39 years
- Anovulation with oligomenorrhoea (> 35 days of mean cycle length) or amenorrhoea
- Normal serum FSH (< 10 IU/l)
- Two ovaries
Key exclusion criteria (12 listed)
- A history of >12 ovulation induction cycles without achieving pregnancy.
- More than three earlier gonadotropin cycles at other clinics or earlier treatments with threshold doses below 75.
- Known hyperprolactinaemia or any other endocrine disturbance or systemic disease of the pituitary gland, thyroid gland, adrenal gland, pancreas, liver or kidney.
- Undiagnosed vaginal bleeding.
- Acute or chronic infection with HIV or hepatitis.
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 |
|---|---|---|
| MenopurThe medication used in this study is the follicle-stimulating hormone "highly purified human menopausal gonadotrophin" (HP-HMG), Menopur, (Ferring a/s). Stimulation with HP-hMG (Menopur) is started on day 2-5 of menstrual bleeding.The HP-hMG starting dose is calculated based on the nomogram predicting the threshold dose. The dose-range is from 75 IU/day to 187.5 IU/day. | Drug | Ovulation induction |
Primary outcome
The proportion of patients who reach the criteria for hCG-administration within 14 days of FSH stimulation.
Time frame: 14 days of FSH stimulation
The HCG-criteria is defined as: 1. One follicle with a diameter of >17 mm or two or three follicles > 15 mm (verified by transvaginal ultrasound). 2. HCG should not be given if there is no response after 35 days or > 4 follicles > 15 mm (unless converted to IVF/ICSI). 3. If a patient is seen with one to three follicles of 15 - 16 mms HCG can be administered on the same or on the next day due to a presumed growth of follicles of + 2 mm/day.
1 secondary outcome
Endocrinological characteristics and follicular dynamics of anovulatory infertility WHO Group II
Time frame: 35 days
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 19 Apr 2013.
- Background: PubMed 18372254Nyboe Andersen A, Balen A, Platteau P, Devroey P, Helmgaard L, Arce JC; Bravelle Ovulation Induction (BOI) Study Group. Predicting the FSH threshold dose in women with WHO Group II anovulatory infertility failing to ovulate or conceive on clomiphene citrate. Hum Reprod. 2008 Jun;23(6):1424-30. doi: 10.1093/humrep/den089. Epub 2008 Mar 26.
- Background: PubMed 16571641Platteau P, Andersen AN, Balen A, Devroey P, Sorensen P, Helmgaard L, Arce JC; Menopur Ovulation Induction (MOI) Study Group. Similar ovulation rates, but different follicular development with highly purified menotrophin compared with recombinant FSH in WHO Group II anovulatory infertility: a randomized controlled study. Hum Reprod. 2006 Jul;21(7):1798-804. doi: 10.1093/humrep/del085. Epub 2006 Mar 29.
Related trials for Anovulation
RecruitingPhase 2
A Study to Investigate Mibavademab in Adult Women With Functional Hypothalamic Amenorrhea
Functional Hypothalamic Amenorrhea, FHA
Not yet recruitingObservational study
Half-dose vs Conventional-dose Cetrorelix in ICSI Cycles
Infertility, Infertility, Female
Recruiting
Sperm Preparation Prior to Intrauterine Insemination Study
Infertility, Infertility Secondary
Not yet recruiting
Ovarian Stromal Stiffness and Ovarian Reserve Parameters Via Transvaginal Shear Wave Elastography
Ovarian Reserve Markers, Ovarian Function
RecruitingPhase 2/3
Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women
Infertility, Female, Anovulatory Infertility
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.
Mette P Lauritsen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
Anders N Andersen, Prof. MD study chair
Copenhagen University Hospital, Rigshospitalet
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 Menopur in people with Anovulation and Infertility, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 9 inclusion and 12 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 19 Apr 2013. 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 Denmark. 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?
The proportion of patients who reach the criteria for hCG-administration within 14 days of FSH stimulation. (time frame: 14 days of FSH stimulation). 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 NCT01250821, 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 19 Apr 2013.