InfertilityNCT01100346
Predictive Factors of Ovarian Response in Ovulation Induction With Intrauterine Insemination of a Gonal-f Low-dose Regimen
An observational study of Infertility, run by Merck KGaA, Darmstadt, Germany at 1 site in Taiwan.
Trial summary
This is a single center, prospective, observational study on the use of Gonal-f in controlled ovarian hyperstimulation (COH) in subjects undergoing ovulation induction/ intrauterine insemination (OI/IUI) therapy across Taiwan. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Gonal-f (Follitropin alpha)
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2010to Sep 2010
- Phase
- Observational
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Female subjects with regular menstrual cycles aged between 20 and 35 years in Taiwan.
Who may be able to join
- Female subjects aged between 20 and 35 years
- Subjects with regular menstrual cycle of 25 - 35 days
- Subjects with both ovaries
- Subjects with normal uterine cavity as investigated by either ultrasound scan or hysteroscopy and patent fallopian tube
- Subjects with baseline serum FSH level within normal range of the clinic
- Subjects whose male partner's semen is considered adequate for IUI in accordance to the centre's standard practice
Who cannot join
- Subjects with any contraindication to being pregnant and/or carrying a pregnancy to term
- Subjects with extrauterine pregnancy or abortion in the past 3 months
- Subjects with abnormal gynaecological bleeding of undetermined origin
- Subjects with history of OHSS
- Subjects with known hypersensitivity to recombinant FSH preparations or any of their recipients
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Far Eastern Memorial Hospital, No.21 Nan-Ya S. Rd., Sec.2 Pan-Chiao
Taipei
About this study
Official title: A Prospective, Single Center, Observational Study on the Predictive Factors of Ovarian Response in Ovulation Induction (OI) With Intrauterine Insemination (IUI) of a Gonal-f Low-dose Step-up Regimen
This is a single center, prospective, observational study on the use of Gonal-f in controlled ovarian hyperstimulation (COH) in subjects undergoing ovulation induction/ intrauterine insemination (OI/IUI) therapy across Taiwan. It has been observed in the previous studies that COH with follicle stimulating hormone (FSH) is considered as one of the positive predictors of an ongoing pregnancy. Many studies in the past have tried to predict the FSH threshold, defined as the FSH dose on the day when a follicle is >10 mm in diameter, but no studies have been conducted to date to determine the predictive factors for a monofollicular development after COH in IUI cycles. Monofollicular growth contributes significantly to the reduction of multiple pregnancies and thus minimize the risks associated with such pregnancies. This study would provide preliminary data on the factors associated with a monofollicular development in Gonal-f treated cycles using a low dose step-up regimen.
Read the detailed description
Ovarian stimulation improves the cycle fecundity rate in part by increasing the number of follicles available for fertilisation and correcting subtle, unpredictable ovulatory dysfunction. Intrauterine insemination is an established treatment for subfertility due to cervical factors, male factors, or unexplained etiology. Ovulation induction aims at the selection of a single follicle that would be able to reach the pre-ovulatory size and rupture. The ovarian sensitivity to FSH (FSH threshold) has to be identified to avoid multiple follicular development and hence, the lowest effective dose of FSH should be used in treating infertility.
Treatment in subjects is individualised and is monitored by serum estradiol (E2) measurements and ultrasound scans of the ovaries to assess the endometrial thickness. It has been observed in earlier studies that in OI for unexplained non-conception, induction of more than one follicle did not improve the ongoing pregnancy rate but increased the risk of multiple pregnancies. Therefore, to reduce the number of multiple pregnancies, in all IUI cycles for unexplained non-conception, monofollicular growth was suggested.
The 'low-dose step-up' protocol is the most suitable method to establish an appropriate FSH threshold, which involves a starting FSH dose of 75 IU/day given for 7 to 14 days. Subsequent dose increments of 37.5 IU/day at weekly intervals is determined based on the ovarian response, usually when a follicle of diameter ≥10 mm is not seen in the ovaries. Human chorionic gonadotrophin (hCG) is then injected when the leading follicle is ≥18 mm in diameter.
OBJECTIVES
Primary objective:
- To describe the outcome of treatment in a cohort of subjects undergoing OI/IUI therapy using Gonal-f
Secondary objective:
- To explore the predictive factors of ovarian response in OI/IUI therapy using a low-dose step-up regimen
This study is planned to enrol 30 female subjects from 1 centre in Taiwan. Each subject can receive up to 3 treatment cycles. Before undergoing a controlled ovarian stimulation with Gonal-f, a thorough gynaecologic and endocrinologic evaluation of the subject will be performed and the subjects will be given the first administration of Gonal-f low dose step up regimen for the controlled ovarian stimulation at the baseline visit. The objective of the Gonal-f therapy is to develop a single mature graafian follicle from which the ovum will be liberated after the administration of hCG. If a subject fails to respond adequately after 4 weeks of treatment, the cycle will be abandoned and the subject would recommence the treatment at a higher starting dose than in the abandoned cycle. If an excessive response is obtained, treatment would be stopped and hCG administration will be withheld and in the next cycle the treatment would start at a dosage lower than that of the previous cycle. Each enrolled subject will be followed up until the confirmation of her pregnancy status.
- Conditions
- Infertility
- Being tested
- Gonal-f (Follitropin alpha)
- Keywords
- Ovulation induction, Intrauterine insemination, Gonal-f, Controlled ovarian stimulation, Infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonal-f (Follitropin alpha)Drug
Also called Gonal-f
A starting dose of 75 IU/day subcutaneously is maintained for a period of 7 to 14 days. The follitropin alpha dose would be subsequently increased by 37.5 IU/day at weekly intervals based on the ovarian response.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of follicles 11-15 mm and ≥ 16 mm in diameter, estradiol (E2) levels and endometrial thickness
Measured: On the day of hCG administration (during 24-48 hrs after the last Gonal-f injection)
Total dose of Gonal-f used during stimulation, threshold of Gonal-f dose (daily dose of Gonal-f when follicular growth is > 11 mm in diameter)and duration of Gonal-f treatment
Measured: During the period of ovarian stimulation
Outcomes of the treatment (Pregnancy status)
Clinical pregnancy, multiple pregnancy, miscarriage, cycle cancellation, Ovarian hyperstimulation syndrome (OHSS) and severity.
Measured: Stimulation start to pregnancy assessment
Secondary outcomes (1)
Proportion of subjects with monofollicular development
Measured: On the day of hCG administration (during 24-48 hrs after the last Gonal-f injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Ltd., Taiwan
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Ltd., Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100346
- Sponsor's protocol ID
- EMR 700623-509
- Status last verified
- Nov 2012
- First submitted
- 10 Mar 2010
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Center, Observational Study on the Predictive Factors of Ovarian Response in Ovulation Induction (OI) With Intrauterine Insemination (IUI) of a Gonal-f Low-dose Step-up Regimen
- ClinicalTrials.gov ID
- NCT01100346
- Acronym / sponsor ID
- EMR 700623-509
- Conditions
- Infertility
- Keywords
- Ovulation induction, Intrauterine insemination, Gonal-f, Controlled ovarian stimulation, Infertility
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Ltd., Taiwan
- Study start
- Jan 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 8 Apr 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.
This is a single center, prospective, observational study on the use of Gonal-f in controlled ovarian hyperstimulation (COH) in subjects undergoing ovulation induction/ intrauterine insemination (OI/IUI) therapy across Taiwan. It has been observed in the previous studies that COH with follicle stimulating hormone (FSH) is considered as one of the positive predictors of an ongoing pregnancy. Many studies in the past have tried to predict the FSH threshold, defined as the FSH dose on the day when a follicle is >10 mm in diameter, but no studies have been conducted to date to determine the predictive factors for a monofollicular development after COH in IUI cycles. Monofollicular growth contributes significantly to the reduction of multiple pregnancies and thus minimize the risks associated with such pregnancies. This study would provide preliminary data on the factors associated with a monofollicular development in Gonal-f treated cycles using a low dose step-up regimen.
Detailed description
Ovarian stimulation improves the cycle fecundity rate in part by increasing the number of follicles available for fertilisation and correcting subtle, unpredictable ovulatory dysfunction. Intrauterine insemination is an established treatment for subfertility due to cervical factors, male factors, or unexplained etiology. Ovulation induction aims at the selection of a single follicle that would be able to reach the pre-ovulatory size and rupture. The ovarian sensitivity to FSH (FSH threshold) has to be identified to avoid multiple follicular development and hence, the lowest effective dose of FSH should be used in treating infertility.
Treatment in subjects is individualised and is monitored by serum estradiol (E2) measurements and ultrasound scans of the ovaries to assess the endometrial thickness. It has been observed in earlier studies that in OI for unexplained non-conception, induction of more than one follicle did not improve the ongoing pregnancy rate but increased the risk of multiple pregnancies. Therefore, to reduce the number of multiple pregnancies, in all IUI cycles for unexplained non-conception, monofollicular growth was suggested.
The 'low-dose step-up' protocol is the most suitable method to establish an appropriate FSH threshold, which involves a starting FSH dose of 75 IU/day given for 7 to 14 days. Subsequent dose increments of 37.5 IU/day at weekly intervals is determined based on the ovarian response, usually when a follicle of diameter ≥10 mm is not seen in the ovaries. Human chorionic gonadotrophin (hCG) is then injected when the leading follicle is ≥18 mm in diameter.
OBJECTIVES
Primary objective:
- To describe the outcome of treatment in a cohort of subjects undergoing OI/IUI therapy using Gonal-f
Secondary objective:
- To explore the predictive factors of ovarian response in OI/IUI therapy using a low-dose step-up regimen
This study is planned to enrol 30 female subjects from 1 centre in Taiwan. Each subject can receive up to 3 treatment cycles. Before undergoing a controlled ovarian stimulation with Gonal-f, a thorough gynaecologic and endocrinologic evaluation of the subject will be performed and the subjects will be given the first administration of Gonal-f low dose step up regimen for the controlled ovarian stimulation at the baseline visit. The objective of the Gonal-f therapy is to develop a single mature graafian follicle from which the ovum will be liberated after the administration of hCG. If a subject fails to respond adequately after 4 weeks of treatment, the cycle will be abandoned and the subject would recommence the treatment at a higher starting dose than in the abandoned cycle. If an excessive response is obtained, treatment would be stopped and hCG administration will be withheld and in the next cycle the treatment would start at a dosage lower than that of the previous cycle. Each enrolled subject will be followed up until the confirmation of her pregnancy status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female subjects with regular menstrual cycles aged between 20 and 35 years in Taiwan.
Key inclusion criteria (6 listed)
- Female subjects aged between 20 and 35 years
- Subjects with regular menstrual cycle of 25 - 35 days
- Subjects with both ovaries
- Subjects with normal uterine cavity as investigated by either ultrasound scan or hysteroscopy and patent fallopian tube
- Subjects with baseline serum FSH level within normal range of the clinic
Key exclusion criteria (5 listed)
- Subjects with any contraindication to being pregnant and/or carrying a pregnancy to term
- Subjects with extrauterine pregnancy or abortion in the past 3 months
- Subjects with abnormal gynaecological bleeding of undetermined origin
- Subjects with history of OHSS
- Subjects with known hypersensitivity to recombinant FSH preparations or any of their recipients
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 |
|---|---|---|
| Gonal-f (Follitropin alpha)Also: Gonal-fA starting dose of 75 IU/day subcutaneously is maintained for a period of 7 to 14 days. The follitropin alpha dose would be subsequently increased by 37.5 IU/day at weekly intervals based on the ovarian response. | Drug | – |
Primary outcome
Number of follicles 11-15 mm and ≥ 16 mm in diameter, estradiol (E2) levels and endometrial thickness
Time frame: On the day of hCG administration (during 24-48 hrs after the last Gonal-f injection)
Total dose of Gonal-f used during stimulation, threshold of Gonal-f dose (daily dose of Gonal-f when follicular growth is > 11 mm in diameter)and duration of Gonal-f treatment
Time frame: During the period of ovarian stimulation
Outcomes of the treatment (Pregnancy status)
Time frame: Stimulation start to pregnancy assessment
Clinical pregnancy, multiple pregnancy, miscarriage, cycle cancellation, Ovarian hyperstimulation syndrome (OHSS) and severity.
1 secondary outcome
Proportion of subjects with monofollicular development
Time frame: On the day of hCG administration (during 24-48 hrs after the last Gonal-f injection)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2014.
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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.
Medical Responsible study director
Merck Ltd., Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Merck KGaA, Darmstadt, Germany at 1 site in Taiwan.
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 5 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: stopped early, as of the sponsor's last update on 18 Mar 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 Taiwan. 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 was stopped early. Results are not available in the source record.
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 follicles 11-15 mm and ≥ 16 mm in diameter, estradiol (E2) levels and endometrial thickness (time frame: On the day of hCG administration (during 24-48 hrs after the last Gonal-f injection)). The study lists 3 primary outcomes in all. 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 18 Mar 2014.