Compare Pregnancy Rates Between FSH Stimulation and FSH andNCT01286051
Single Injection of Ganirelix in Gonadotropin Intrauterine Insemination (IUI) Cycles
A study testing Follistim administration and Follistim plus Ganirelix in people with Compare Pregnancy Rates Between FSH Stimulation and FSH and and GnRH Antagonist, run by Houston Fertility Institute at 1 site in United States.
Trial summary
Ovulation induction (OI) using gonadotropins is one of the most widely prescribed treatments of infertility. One common problem encountered while attempting OI using gonadotropins is premature ovulation. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Compare Pregnancy Rates Between FSH Stimulation and FSH and, GnRH Antagonist
- What is being tested?
- Follistim administration and Follistim plus Ganirelix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Sep 2012
- 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 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing ovulation induction (OI) between ages 18 - 39 years.
- One or more of the following infertility diagnoses: ovulation dysfunction, mild male factor infertility (sperm concentration of 5- 20 million/ml, and/or sperm motility 10% - 40%) , absence teratospermia (i.e. strict morphology > 4%), unexplained infertility.
- Patent Fallopian tubes.
- Normal uterine structure (i.e. absence of mullerian anomalies)
- Ability to consent to the study.
- Patients should be Houston Fertility Institute patients
Who cannot join
- Age 39 or above
- Severe male factor (concentration < 10 million/ml or strict morphology < 4%)
- Obstructed Fallopian tubes on one or both sides
- Stage III or IV endometriosis
- Elevated FSH level (>10 IU/L)
- Low antral follicular count (< 4 antral follicles per ovary)
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- Any other contraindication for ovulation induction
- Inability to consent to the study
- History of any prior failed OI/IUI cycle
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Single Dose Ganirelix in Gonadotropin Ovulation Induction Cycles
Ovulation induction (OI) using gonadotropins is one of the most widely prescribed treatments of infertility. One common problem encountered while attempting OI using gonadotropins is premature ovulation. The purpose of this study is to examine the effect of a single injection of a medication, called ganirelix, to prevent premature ovulation. Patients will be divided into two groups. In the first group, gonadotropins will be used to stimulate the ovaries. In the second group gonadotropins will be used in addition to a single injection of ganirelix, a gonadotropin releasing hormone (GnRH) antagonist. Pregnancy rates will be compared between groups.
Read the detailed description
A randomized prospective study will be performed on patients attempting pregnancy using ovulation induction/intra-uterine insemination (IUI). Patients will be randomly assigned to one of two protocols:
Protocol A (control group): On menstrual cycle day 3, the patient will start gonadotropins (Follistim) injections at a starting dose of 75-150 IU and monitored according to the discretion of the treating physician. When the leading follicle reaches a size of at least 18mm, intramuscular human chorionic gonadotripin (hCG) (10,000 IU) is administered, followed by two inseminations, one at 12 hours after hCG, and the other at 36 hours. All patients will have luteal support using progesterone vaginal suppositories at a dose of 200mg two times per day (BID). Pregnancy testing will be scheduled at 2 weeks after the IUI. The treatment cycle typically lasts from 8-13 days, depending on the patient's response.
Protocol B (study group): On menstrual cycle day 3, the patient will start gonadotropins (Follistim) injections at a starting dose of 75-150 IU and monitored according to the discretion of the treating physician. When the leading follicle reaches a size of 13-14mm in mean diameter, or when the estradiol level reaches a level of 400 pg/ml, ganirelix injection at the standard dose of 250mcg is given once subcutaneously. When the leading follicle reaches a size of at least 18mm, intramuscular hCG (10,000IU) is administered followed by two inseminations, one at 12 hours after hCG, and the other at 36 hours. All patients will have luteal support using progesterone suppositories at a dose of 200mg BID. Pregnancy testing will be scheduled at 2 weeks after the IUI. The treatment cycle typically lasts from 8-13 days, depending on the patient's response.
Patients will be randomized, via computer generated program, in a 1:1 fashion.
- Being tested
- Follistim administration, Follistim plus Ganirelix
- Keywords
- ovulation induction, GnRH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follistim administrationDrug
Also called Follistim
adminstation of FSH for ovulation induction
Follistim plus GanirelixDrug
Also called Follistim, ganirelix
Follistim plus single injection of ganirelix
| Study group | Role | What they receive |
|---|---|---|
| Follistim | Active comparator | standard treatment Receives: Drug: Follistim administration |
| Follistim plus single ganirelix injection | Experimental | Not described Receives: Drug: Follistim plus Ganirelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rates
Follicle stimulating hormone (FSH) and IUI
Measured: One cycle of controlled ovarian stimulation (one month)
Secondary outcomes (1)
Premature leuteinizing hormone (LH) surge and ovulation
pregnancy rate in one cycle of FSH and single injection of GnRH antagonist
Measured: One cycle of controlled ovarian stimulation (one month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compare Pregnancy Rates Between FSH Stimulation and FSH andStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Houston Fertility Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghassan F. Haddad, Houston Fertility Institute
- Investigators
- Ghassan F Haddad, M.D., Principal investigator, Houston Fertility Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286051
- Sponsor's protocol ID
- P08115
- Status last verified
- Mar 2013
- First submitted
- 25 Jan 2011
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Single Dose Ganirelix in Gonadotropin Ovulation Induction Cycles
- ClinicalTrials.gov ID
- NCT01286051
- Acronym / sponsor ID
- P08115
- Keywords
- ovulation induction, GnRH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Houston Fertility InstituteUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 31 Jan 2011 (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 induction (OI) using gonadotropins is one of the most widely prescribed treatments of infertility. One common problem encountered while attempting OI using gonadotropins is premature ovulation. The purpose of this study is to examine the effect of a single injection of a medication, called ganirelix, to prevent premature ovulation. Patients will be divided into two groups. In the first group, gonadotropins will be used to stimulate the ovaries. In the second group gonadotropins will be used in addition to a single injection of ganirelix, a gonadotropin releasing hormone (GnRH) antagonist. Pregnancy rates will be compared between groups.
Detailed description
A randomized prospective study will be performed on patients attempting pregnancy using ovulation induction/intra-uterine insemination (IUI). Patients will be randomly assigned to one of two protocols:
Protocol A (control group): On menstrual cycle day 3, the patient will start gonadotropins (Follistim) injections at a starting dose of 75-150 IU and monitored according to the discretion of the treating physician. When the leading follicle reaches a size of at least 18mm, intramuscular human chorionic gonadotripin (hCG) (10,000 IU) is administered, followed by two inseminations, one at 12 hours after hCG, and the other at 36 hours. All patients will have luteal support using progesterone vaginal suppositories at a dose of 200mg two times per day (BID). Pregnancy testing will be scheduled at 2 weeks after the IUI. The treatment cycle typically lasts from 8-13 days, depending on the patient's response.
Protocol B (study group): On menstrual cycle day 3, the patient will start gonadotropins (Follistim) injections at a starting dose of 75-150 IU and monitored according to the discretion of the treating physician. When the leading follicle reaches a size of 13-14mm in mean diameter, or when the estradiol level reaches a level of 400 pg/ml, ganirelix injection at the standard dose of 250mcg is given once subcutaneously. When the leading follicle reaches a size of at least 18mm, intramuscular hCG (10,000IU) is administered followed by two inseminations, one at 12 hours after hCG, and the other at 36 hours. All patients will have luteal support using progesterone suppositories at a dose of 200mg BID. Pregnancy testing will be scheduled at 2 weeks after the IUI. The treatment cycle typically lasts from 8-13 days, depending on the patient's response.
Patients will be randomized, via computer generated program, in a 1:1 fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follistim | Active comparator | Drug: Follistim administrationstandard treatment |
| Follistim plus single ganirelix injection | Experimental | Drug: Follistim plus Ganirelix |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients undergoing ovulation induction (OI) between ages 18 - 39 years.
- One or more of the following infertility diagnoses: ovulation dysfunction, mild male factor infertility (sperm concentration of 5- 20 million/ml, and/or sperm motility 10% - 40%) , absence teratospermia (i.e. strict morphology > 4%), unexplained infertility.
- Patent Fallopian tubes.
- Normal uterine structure (i.e. absence of mullerian anomalies)
- Ability to consent to the study.
Key exclusion criteria (9 listed)
- Age 39 or above
- Severe male factor (concentration < 10 million/ml or strict morphology < 4%)
- Obstructed Fallopian tubes on one or both sides
- Stage III or IV endometriosis
- Elevated FSH level (>10 IU/L)
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 |
|---|---|---|
| Follistim administrationAlso: Follistimadminstation of FSH for ovulation induction | Drug | Follistim |
| Follistim plus GanirelixAlso: Follistim, ganirelixFollistim plus single injection of ganirelix | Drug | Follistim plus single ganirelix injection |
Primary outcome
Pregnancy rates
Time frame: One cycle of controlled ovarian stimulation (one month)
Follicle stimulating hormone (FSH) and IUI
1 secondary outcome
Premature leuteinizing hormone (LH) surge and ovulation
Time frame: One cycle of controlled ovarian stimulation (one month)
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 20 Mar 2013.
- practice websiteLink provided by the sponsor.
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.
Ghassan F Haddad, M.D. principal investigator
Houston Fertility Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follistim administration and Follistim plus Ganirelix in people with Compare Pregnancy Rates Between FSH Stimulation and FSH and and GnRH Antagonist, run by Houston Fertility Institute 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 6 inclusion and 9 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 20 Mar 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 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?
Pregnancy rates (time frame: One cycle of controlled ovarian stimulation (one month)). 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 20 Mar 2013.