Infertility, FemalePhase 2/3NCT03139474
Impact of Gonadotrophin Releasing Hormone Analogues on Oocyte and Embryo Quality
A Phase 2/3 study testing Gonadotropin-Releasing Hormone Analogue and Gonadotropin releasing hormone antagonist in people with Infertility, Female, run by Assiut University.
Trial summary
The first In-Vitro Fertilization cycles were performed in natural unstimulated cycles. Today gonadotrophins are administered to induce multiple follicular development and controlled ovarian hyperstimulation. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Gonadotropin-Releasing Hormone Analogue and Gonadotropin releasing hormone antagonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 1 Jun 2020
- Phase
- Phase 2/3
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Unexplained infertility.
- Tubal factor. Included treated hydrosalpinx and pyosalpinx
- first cycle .
- Body mass index: 18-29.
- Follicle stimulating hormone not more than 14 , E2 not more than 80 and Antimullerian hormone >1.
- Antral follicular count: more than 5 follicles in one ovary.
- combined factors .
- Normal male semen analysis: Mild male factor: concentrations 10 million - 20 million sperm/ml. Moderate male factor : concentrations 5 million - 10 million sperm/ml.
Who cannot join
- Patients with Endometriosis.
- Azoospermic male.
- Body mass index more than 29.
About this study
Official title: Impact of Gonadotrophin Releasing Hormone Analogues on Oocyte and Embryo Quality in Intracytoplasmic Sperm Injection Cycles.
The first In-Vitro Fertilization cycles were performed in natural unstimulated cycles. Today gonadotrophins are administered to induce multiple follicular development and controlled ovarian hyperstimulation. During ovarian stimulation gonadotrophin-releasing hormone analogues are co-administered in order to prevent premature luteinizing hormone surges. Premature luteinizing hormone surges are observed in about 20% of stimulated cycles without using gonadotrophin-releasing hormone analogues .
Avoiding the adverse effects of elevated luteinizing hormone levels, first gonadotrophin-releasing hormone agonist analogues were used to supplement the gonadotrophin stimulation. The continuous administration of gonadotrophin-releasing hormone agonists causes gonadotrophin suppression through down-regulation and desensitization of the gonadotrophin-releasing hormone receptors in the pituitary gland after an initial short period of gonadotrophin hypersecretion .
Gonadotrophin-releasing hormone antagonists (cetrorelix and ganirelix) cause immediate and rapid gonadotrophin suppression by competitive antagonism of the gonadotrophin-releasing hormone receptor in the pituitary without an initial period of gonadotrophin hypersecretion. Several advantageous effects of cetrorelix were established , and these effects seemed to be independent from the type of antagonist used for luteinizing hormone-suppression.The quality of oocytes and developing preembryos is one of the most relevant factors determining the success of an In-Vitro Fertilization treatment. As ovarian stimulation protocol is one of the eligible factors during an In-Vitro Fertilization treatment, its embryo quality influencing effects are necessary to know.
- Conditions
- Infertility, Female
- Being tested
- Gonadotropin-Releasing Hormone Analogue, Gonadotropin releasing hormone antagonist
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonadotropin-Releasing Hormone AnalogueDrug
Triptorelin at a dose 1 mg per day from the midluteal phase of the cycle preceding the treatment cycle to day 2 of the cycle then 0.5 milligram of triptorelin will be used during the period of stimulation.
Gonadotropin releasing hormone antagonistDrug
antagonist group :Multiple dose gonadotrophin-releasing hormone antagonist regimen will be used for ovarian stimulation 0.25 microgram per day cetrorelix will be administered from the 6th day of ovarian stimulation or from the presence of follicle 14 millimeter diameter .We will give them gonadotrophin for 5 days , Triggering by Human Chorionic Gonadotrophin will be administered for each group when size of follicle reach > 17 millimeter .Oocytes will retrieved by transvaginal ultrasound , 34-36 hours after Human Chorionic Gonadotrophin administration .
| Study group | Role | What they receive |
|---|---|---|
| agonist group | Active comparator | Triptorelin at a dose 1 milligram per day from the midluteal phase of the cycle preceding the treatment cycle to day 2 of the cycle then 0.5 milligram of triptorelin will be used during the period of stimulation. Receives: Drug: Gonadotropin-Releasing Hormone Analogue |
| antagonist group | Active comparator | •Multiple dose Gonadotrophin releasing hormone antagonist regimen will be used for ovarian stimulation 0.25 microgram per day cetrorelix will be administered from the 6th day of ovarian stimulation or from the presence of follicle 14 millimeter diameter . Receives: Drug: Gonadotropin releasing hormone antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of maturated oocyte and good quality embryoes
Measured: 14 days
Secondary outcomes (1)
clinical pregnancy outcome
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start1 Jun 2017 (estimated)
- Primary completion1 Jun 2019 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Traiza Helal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139474
- Sponsor's protocol ID
- HYY
- Status last verified
- May 2017
- First submitted
- 2 May 2017
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gonadotrophin Releasing Hormone Analogues on Oocyte and Embryo Quality in Intracytoplasmic Sperm Injection Cycles.
- ClinicalTrials.gov ID
- NCT03139474
- Acronym / sponsor ID
- HYY
- Conditions
- Infertility, Female
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 1 Jun 2019 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 4 May 2017 (actual)
- 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.
The first In-Vitro Fertilization cycles were performed in natural unstimulated cycles. Today gonadotrophins are administered to induce multiple follicular development and controlled ovarian hyperstimulation. During ovarian stimulation gonadotrophin-releasing hormone analogues are co-administered in order to prevent premature luteinizing hormone surges. Premature luteinizing hormone surges are observed in about 20% of stimulated cycles without using gonadotrophin-releasing hormone analogues .
Avoiding the adverse effects of elevated luteinizing hormone levels, first gonadotrophin-releasing hormone agonist analogues were used to supplement the gonadotrophin stimulation. The continuous administration of gonadotrophin-releasing hormone agonists causes gonadotrophin suppression through down-regulation and desensitization of the gonadotrophin-releasing hormone receptors in the pituitary gland after an initial short period of gonadotrophin hypersecretion .
Gonadotrophin-releasing hormone antagonists (cetrorelix and ganirelix) cause immediate and rapid gonadotrophin suppression by competitive antagonism of the gonadotrophin-releasing hormone receptor in the pituitary without an initial period of gonadotrophin hypersecretion. Several advantageous effects of cetrorelix were established , and these effects seemed to be independent from the type of antagonist used for luteinizing hormone-suppression.The quality of oocytes and developing preembryos is one of the most relevant factors determining the success of an In-Vitro Fertilization treatment. As ovarian stimulation protocol is one of the eligible factors during an In-Vitro Fertilization treatment, its embryo quality influencing effects are necessary to know.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| agonist group | Active comparator | Drug: Gonadotropin-Releasing Hormone AnalogueTriptorelin at a dose 1 milligram per day from the midluteal phase of the cycle preceding the treatment cycle to day 2 of the cycle then 0.5 milligram of triptorelin will be used during the period of stimulation. |
| antagonist group | Active comparator | Drug: Gonadotropin releasing hormone antagonist•Multiple dose Gonadotrophin releasing hormone antagonist regimen will be used for ovarian stimulation 0.25 microgram per day cetrorelix will be administered from the 6th day of ovarian stimulation or from the presence of follicle 14 millimeter diameter . |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Unexplained infertility.
- Tubal factor. Included treated hydrosalpinx and pyosalpinx
- first cycle .
- Body mass index: 18-29.
- Follicle stimulating hormone not more than 14 , E2 not more than 80 and Antimullerian hormone >1.
Key exclusion criteria (3 listed)
- Patients with Endometriosis.
- Azoospermic male.
- Body mass index more than 29.
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 |
|---|---|---|
| Gonadotropin-Releasing Hormone AnalogueTriptorelin at a dose 1 mg per day from the midluteal phase of the cycle preceding the treatment cycle to day 2 of the cycle then 0.5 milligram of triptorelin will be used during the period of stimulation. | Drug | agonist group |
| Gonadotropin releasing hormone antagonistantagonist group :Multiple dose gonadotrophin-releasing hormone antagonist regimen will be used for ovarian stimulation 0.25 microgram per day cetrorelix will be administered from the 6th day of ovarian stimulation or from the presence of follicle 14 millimeter diameter .We will give them gonadotrophin for 5 days , Triggering by Human Chorionic Gonadotrophin will be administered for each group when size of follicle reach > 17 millimeter .Oocytes will retrieved by transvaginal ultrasound , 34-36 hours after Human Chorionic Gonadotrophin administration . | Drug | antagonist group |
Primary outcome
number of maturated oocyte and good quality embryoes
Time frame: 14 days
1 secondary outcome
clinical pregnancy outcome
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Gonadotropin-Releasing Hormone Analogue and Gonadotropin releasing hormone antagonist in people with Infertility, Female, run by Assiut University.
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 3 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 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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 maturated oocyte and good quality embryoes (time frame: 14 days). 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 4 May 2017.