InfertilityPhase 4NCT02140515
Comparison of Assisted Reproductive Technology (ART) Outcomes Between Two Protocols of Induction of Ovulation in Patients With Hypogonadotropic Hypogonadism
A Phase 4 study testing Lutropin alfa and Follitropin alfa and Lutropin alfa in people with Infertility, run by Royan Institute at 1 site in Iran.
Trial summary
We wanted to compare the Assisted Reproductive Technology (ART) outcomes between two protocols of induction of ovulation in patients with Hypogonadotropic Hypogonadism. In the beginning, all patients receive Recombinant Follicle Stimulating Hormone (Gonal-F) and Recombinant Luteinizing Hormone (Luveris). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infertility
- What is being tested?
- Lutropin alfa and Follitropin alfa and Lutropin alfa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- Nov 2012to Nov 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have a clinical history of hypogonadotropic hypogonadism, and laboratory test result comply with diagnosis of hypogonadotropic hypogonadism
- Have discontinued gonadotropins or gonadotropin releasing hormone or estrogen-progesterone replacement therapy at least one month before the study
- Have primary or secondary amenorrhea
- Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) <5.0 IU/l and oestradiol <100 pg/ml before initiation of treatment
- Have a negative progesterone challenge test
- Normal serum concentrations of thyroid stimulating hormone (TSH), prolactin and testosterone within 6 months before the start of study
- Be willing and able to comply with the protocol for the duration of the study
- Have given written informed consent prior to any study related procedure
Who cannot join
- The other causes of infertility.
- History of ovarian hyper stimulation syndrome
- Abnormal gynecological bleeding of undetermined origin
- Previous or current hormone dependent tumor
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Royan Institute
Tehran
Nasser Aghdami, MD,PhD, (+98)2123562000 ext. 516, nasser.aghdami@royaninstitute.org
Leila Arab, m, (+98)23562000 ext. 414, Leara91@gmail.com
About this study
Official title: Comparison of Assisted Reproductive Technology (ART) Outcomes Between Two Protocols of Induction of Ovulation by Using Recombinant Luteinizing Hormone (rLH) and Recombinant Follicle Stimulating Hormone (rFSH) in Patients With Hypogonadotropic Hypogonadism
We wanted to compare the Assisted Reproductive Technology (ART) outcomes between two protocols of induction of ovulation in patients with Hypogonadotropic Hypogonadism. In the beginning, all patients receive Recombinant Follicle Stimulating Hormone (Gonal-F) and Recombinant Luteinizing Hormone (Luveris). When at least one follicle reaches 14 mm in diameter, Luveris alone is administered for group A and both drugs Gonal-F and Luveris for group B. Finally Assisted Reproductive Technology (ART) results are compared between the two groups.
Read the detailed description
In this single blind randomized clinical trial, 90 women with a clinical history of hypogonadotrophic hypogonadism who stopped any treatment with gonadotrophins >1 month before study, with a negative progesterone challenge test, low serum gonadotrophins (Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) less than 5.0 IU/l) and oestradiol (less than 100 pg/ml) and normal serum concentrations of thyroid stimulating hormone (TSH), testosterone and prolactin within 6 months before the start of treatment are studied in the Royan Institute. Other causes of infertility are excluded from the study. All patients receive treatment with recombinant follicle stimulating hormone (Gonal-F) and recombinant luteinizing hormone (Luveris). When at least one follicle reaches 14 mm in diameter, 4mg/day oestradiol is administered and patients are randomly divided into two groups: Luveris alone (intervention group) and continued treatment with both drugs Gonal-F and Luveris (control group). When at least one follicle detects a mean diameter of ≥18 mm and serum estradiol level reaches 500-2000 pg/ml, ovarian stimulation is stopped and injection of 10000 IU Human Chorionic Gonadotrophin (hCG) is administrated.
At the end, the number and size of ovarian follicles, endometrial thickness on the day of injection of Human Chorionic Gonadotrophin (hCG), the number of oocytes retrieved, the number of good quality embryos, chemical and clinical pregnancy rate, fertilization rate and implantation rate will be compared between the two groups.
- Conditions
- Infertility
- Being tested
- Lutropin alfa, Follitropin alfa and Lutropin alfa
- Keywords
- Gonal-F Luveris Assisted Reproductive Technology Hypogonadotropic Hypogonadism
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutropin alfaDrug
Also called Follitropin alfa: Gonal-F or recombinant Follicle Stimulating Hormone (rFSH)
Administration of Gonal-F or recombinant Follicle Stimulating Hormone (rFSH)
Follitropin alfa and Lutropin alfaDrug
Also called Follitropin alfa: Gonal-F or recombinant Follicle Stimulating Hormone (rFSH) and, Lutropin alfa: Luveris or Recombinant Luteinizing Hormone (rLH)
Administration of (rFSH) and (rLH)
| Study group | Role | What they receive |
|---|---|---|
| Luveris | Active comparator | Evaluation the effect of Luveris protocol on Induction of ovulation in Patients with Hypogonadotropic Hypogonadism Receives: Drug: Lutropin alfa |
| Gonal-F& Luveris | Active comparator | Evaluation the effect of Gonal-F\& Luveris protocols of Induction of ovulation in Patients with Hypogonadotropic Hypogonadism Receives: Drug: Follitropin alfa and Lutropin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of follicles
Evaluation thre number follicles before injection of Human Chorionic Gonadotrophin (hCG)
Measured: baseline
Size of follicle
Evaluation the size of follicle before injection of Human Chorionic Gonadotrophin (hCG)
Measured: baseline
Endometrial thickness
Evaluation the endometrial thickness at the day of injection of Human Chorionic Gonadotrophin (hCG)
Measured: 1day
Secondary outcomes (5)
number of oocytes retrieved
Evaluation the number of oocytes retrieved 34-36 hours after Human Chorionic Gonadotrophin (hCG) injection
Measured: 3 days
Fertilization rate
Evaluation the fertilization rate 2-3 days before the embryo transfer
Measured: 2 days
Biochemical pregnancy rate
Evaluation the biochemical pregnancy rate 2 weeks after embryo transfer
Measured: 2 weeks
Clinical pregnancy rate
Evaluation the clinical pregnancy rate 4-6 weeks after embryo transfer
Measured: 4 weeks
Implantation rate
Evaluation the implantation rate 4-6 weeks after embryo transfer.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startNov 2012
- Primary completionDec 2015 (estimated)
- Study completionNov 2016 (estimated)
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteTahereh Madani, MD, Study director, Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.Seyedeh Masoumeh Moosavi Sadat, MSc, Principal investigator, Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Centre, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140515
- Sponsor's protocol ID
- royan-Emb-018
- Status last verified
- Aug 2012
- First submitted
- 14 May 2014
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Assisted Reproductive Technology (ART) Outcomes Between Two Protocols of Induction of Ovulation by Using Recombinant Luteinizing Hormone (rLH) and Recombinant Follicle Stimulating Hormone (rFSH) in Patients With Hypogonadotropic Hypogonadism
- ClinicalTrials.gov ID
- NCT02140515
- Acronym / sponsor ID
- royan-Emb-018
- Conditions
- Infertility
- Keywords
- Gonal-F Luveris Assisted Reproductive Technology Hypogonadotropic Hypogonadism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Nov 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 16 May 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.
We wanted to compare the Assisted Reproductive Technology (ART) outcomes between two protocols of induction of ovulation in patients with Hypogonadotropic Hypogonadism. In the beginning, all patients receive Recombinant Follicle Stimulating Hormone (Gonal-F) and Recombinant Luteinizing Hormone (Luveris). When at least one follicle reaches 14 mm in diameter, Luveris alone is administered for group A and both drugs Gonal-F and Luveris for group B. Finally Assisted Reproductive Technology (ART) results are compared between the two groups.
Detailed description
In this single blind randomized clinical trial, 90 women with a clinical history of hypogonadotrophic hypogonadism who stopped any treatment with gonadotrophins >1 month before study, with a negative progesterone challenge test, low serum gonadotrophins (Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) less than 5.0 IU/l) and oestradiol (less than 100 pg/ml) and normal serum concentrations of thyroid stimulating hormone (TSH), testosterone and prolactin within 6 months before the start of treatment are studied in the Royan Institute. Other causes of infertility are excluded from the study. All patients receive treatment with recombinant follicle stimulating hormone (Gonal-F) and recombinant luteinizing hormone (Luveris). When at least one follicle reaches 14 mm in diameter, 4mg/day oestradiol is administered and patients are randomly divided into two groups: Luveris alone (intervention group) and continued treatment with both drugs Gonal-F and Luveris (control group). When at least one follicle detects a mean diameter of ≥18 mm and serum estradiol level reaches 500-2000 pg/ml, ovarian stimulation is stopped and injection of 10000 IU Human Chorionic Gonadotrophin (hCG) is administrated.
At the end, the number and size of ovarian follicles, endometrial thickness on the day of injection of Human Chorionic Gonadotrophin (hCG), the number of oocytes retrieved, the number of good quality embryos, chemical and clinical pregnancy rate, fertilization rate and implantation rate will be compared between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Luveris | Active comparator | Drug: Lutropin alfaEvaluation the effect of Luveris protocol on Induction of ovulation in Patients with Hypogonadotropic Hypogonadism |
| Gonal-F& Luveris | Active comparator | Drug: Follitropin alfa and Lutropin alfaEvaluation the effect of Gonal-F\& Luveris protocols of Induction of ovulation in Patients with Hypogonadotropic Hypogonadism |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Have a clinical history of hypogonadotropic hypogonadism, and laboratory test result comply with diagnosis of hypogonadotropic hypogonadism
- Have discontinued gonadotropins or gonadotropin releasing hormone or estrogen-progesterone replacement therapy at least one month before the study
- Have primary or secondary amenorrhea
- Serum Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) <5.0 IU/l and oestradiol <100 pg/ml before initiation of treatment
- Have a negative progesterone challenge test
Key exclusion criteria (4 listed)
- The other causes of infertility.
- History of ovarian hyper stimulation syndrome
- Abnormal gynecological bleeding of undetermined origin
- Previous or current hormone dependent tumor
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 |
|---|---|---|
| Lutropin alfaAlso: Follitropin alfa: Gonal-F or recombinant Follicle Stimulating Hormone (rFSH)Administration of Gonal-F or recombinant Follicle Stimulating Hormone (rFSH) | Drug | Luveris |
| Follitropin alfa and Lutropin alfaAlso: Follitropin alfa: Gonal-F or recombinant Follicle Stimulating Hormone (rFSH) and, Lutropin alfa: Luveris or Recombinant Luteinizing Hormone (rLH)Administration of (rFSH) and (rLH) | Drug | Gonal-F& Luveris |
Primary outcome
number of follicles
Time frame: baseline
Evaluation thre number follicles before injection of Human Chorionic Gonadotrophin (hCG)
Size of follicle
Time frame: baseline
Evaluation the size of follicle before injection of Human Chorionic Gonadotrophin (hCG)
Endometrial thickness
Time frame: 1day
Evaluation the endometrial thickness at the day of injection of Human Chorionic Gonadotrophin (hCG)
5 secondary outcomes
number of oocytes retrieved
Time frame: 3 days
Fertilization rate
Time frame: 2 days
Biochemical pregnancy rate
Time frame: 2 weeks
Clinical pregnancy rate
Time frame: 4 weeks
Implantation rate
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Related InfoLink provided by the sponsor.
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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.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Tahereh Madani, MD study director
Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran.
Seyedeh Masoumeh Moosavi Sadat, MSc principal investigator
Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Centre, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
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 Lutropin alfa and Follitropin alfa and Lutropin alfa in people with Infertility, run by Royan Institute at 1 site in Iran.
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 8 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: status not confirmed, as of the sponsor's last update on 6 May 2015. 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 Iran. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nasser Aghdami, MD,PhD ((+98)2123562000 ext. 516, nasser.aghdami@royaninstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of follicles (time frame: baseline). 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 6 May 2015.