Female Infertility Due to Diminished Ovarian ReservePhase 4NCT01897324
IVF/ICSI Protocols in Poor Responders With Growth Hormone
A Phase 4 study testing Growth hormone (Norditropin, Novo nordisk) in people with Female Infertility Due to Diminished Ovarian Reserve, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
Trial summary
in this study, we are trying to monitor the effect of the addition of growth hormone on the different down regulation protocols ( long, short, antagonist and microflare). The outcome will be primarily assessed by the clinical pregnancy rates. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Female Infertility Due to Diminished Ovarian Reserve
- What is being tested?
- Growth hormone (Norditropin, Novo nordisk)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2013to Jan 2015
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ESHRE consensus 2011,At least two of the following three features must be present:
- Advanced maternal age (≥40 years) or any other risk factor for POR;
- A previous POR (≤3 oocytes with a conventional stimulation protocol);
- An abnormal ovarian reserve test (i.e. AFC < 5-7 follicles or AMH < 0.5 -1.1 ng/ml).
Who cannot join
- female patients with causes of infertility other than poor ovarian reserve
- females suffering from congenital or acquired uterine anomalies
- females with focal uterine lesions
- females who had previous ovarian surgeries
- females with history of previous exposure to radiotherapy , or chemotherapy
- females refusing to get enrolled in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Which is the Best IVF/ICSI Protocol to be Used in Poor Responders Receiving Growth Hormone as an Adjuvant Treatment ? A Prospective Randomized Study
in this study, we are trying to monitor the effect of the addition of growth hormone on the different down regulation protocols ( long, short, antagonist and microflare). The outcome will be primarily assessed by the clinical pregnancy rates.
Read the detailed description
Poor responders undergoing IVF/ICSI cycles have emerged as a major problem. the need to find a proper stimulation protocol is a must. in this study we are trying to detect the best stimulation protocol ,in addition to growth hormone ,that can give the highest pregnancy rates in these patients.
- Being tested
- Growth hormone (Norditropin, Novo nordisk)
- Keywords
- Poor Ovarian Response, Poor Responders, IVF/ICSI, Growth Hormone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth hormone (Norditropin, Novo nordisk)Drug
| Study group | Role | What they receive |
|---|---|---|
| The Long protocol | Experimental | Patients in the group A received a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) which started on day 21 of preceding cycle at a dose of 0.1 mg/day. On the second day of menstruation HMG was started and this was associated with reduction of triptorelin to 0.05 mg/day. This reduced daily dose was administered until the day hCG was given. Growth hormone co-treatment was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration. Receives: Drug: Growth hormone (Norditropin, Novo nordisk) |
| The Short protocol | Experimental | The short agonist protocol was started on cycle day 1 with triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. Human menopausal gonadotropin IM daily (HMG 75 IU, Merional, IBSA) were also administered starting from days 2 to 3 of cycle. The dose was adjusted for each patient according to the diameter of the follicles detected in their follow up ultrasound. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration. Receives: Drug: Growth hormone (Norditropin, Novo nordisk) |
| The Antagonist protocol | Experimental | Gonadotrophins IM daily (HMG 75 IU, Merional, IBSA)was administrated from day 2 of the cycle. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration. The GnRH antagonist (Cetrotide) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC. Receives: Drug: Growth hormone (Norditropin, Novo nordisk) |
| The Microflare protocol | Experimental | the patients in this group were given oral contraceptive pills (OCPs) for 28 days, this was followed by 2 days free. Triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. was then started daily followed by human menopausal gonadotropin IM daily (HMG 75 IU, Merional, IBSA) 3 days later. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration. Receives: Drug: Growth hormone (Norditropin, Novo nordisk) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of oocytes retrieved and number of fertilized oocytes
Number of oocytes retrieved on the day of vaginal egg collection guided by trans vaginal ultrasound scan , 35 hours after hCG administration.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Female Infertility Due to Diminished Ovarian ReserveStudies 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
- None (open label)
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt
- Investigators
- Dina M Dakhly, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897324
- Sponsor's protocol ID
- WHC2013
- Status last verified
- Oct 2015
- First submitted
- 2 Jul 2013
- Last updated
- 20 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dakhly DM, Bayoumi YA, Gad Allah SH. Which is the best IVF/ICSI protocol to be used in poor responders receiving growth hormone as an adjuvant treatment? A prospective randomized trial. Gynecol Endocrinol. 2016;32(2):116-9. doi: 10.3109/09513590.2015.1092136. Epub 2015 Sep 29.
PubMed 26416521
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Which is the Best IVF/ICSI Protocol to be Used in Poor Responders Receiving Growth Hormone as an Adjuvant Treatment ? A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01897324
- Acronym / sponsor ID
- WHC2013
- Keywords
- Poor Ovarian Response, Poor Responders, IVF/ICSI, Growth Hormone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 11 Jul 2013 (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.
in this study, we are trying to monitor the effect of the addition of growth hormone on the different down regulation protocols ( long, short, antagonist and microflare). The outcome will be primarily assessed by the clinical pregnancy rates.
Detailed description
Poor responders undergoing IVF/ICSI cycles have emerged as a major problem. the need to find a proper stimulation protocol is a must. in this study we are trying to detect the best stimulation protocol ,in addition to growth hormone ,that can give the highest pregnancy rates in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| The Long protocol | Experimental | Drug: Growth hormone (Norditropin, Novo nordisk)Patients in the group A received a long protocol of pituitary down-regulation with triptorelin (Decapeptyl; Ferring, Switzerland) which started on day 21 of preceding cycle at a dose of 0.1 mg/day. On the second day of menstruation HMG was started and this was associated with reduction of triptorelin to 0.05 mg/day. This reduced daily dose was administered until the day hCG was given. Growth hormone co-treatment was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration. |
| The Short protocol | Experimental | Drug: Growth hormone (Norditropin, Novo nordisk)The short agonist protocol was started on cycle day 1 with triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. Human menopausal gonadotropin IM daily (HMG 75 IU, Merional, IBSA) were also administered starting from days 2 to 3 of cycle. The dose was adjusted for each patient according to the diameter of the follicles detected in their follow up ultrasound. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration. |
| The Antagonist protocol | Experimental | Drug: Growth hormone (Norditropin, Novo nordisk)Gonadotrophins IM daily (HMG 75 IU, Merional, IBSA)was administrated from day 2 of the cycle. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration. The GnRH antagonist (Cetrotide) was given when the leading follicle was from 12 to 14 mm, at a daily dose of 0.25 mg SC. |
| The Microflare protocol | Experimental | Drug: Growth hormone (Norditropin, Novo nordisk)the patients in this group were given oral contraceptive pills (OCPs) for 28 days, this was followed by 2 days free. Triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. was then started daily followed by human menopausal gonadotropin IM daily (HMG 75 IU, Merional, IBSA) 3 days later. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Advanced maternal age (≥40 years) or any other risk factor for POR;
- A previous POR (≤3 oocytes with a conventional stimulation protocol);
- An abnormal ovarian reserve test (i.e. AFC < 5-7 follicles or AMH < 0.5 -1.1 ng/ml).
Key exclusion criteria (6 listed)
- female patients with causes of infertility other than poor ovarian reserve
- females suffering from congenital or acquired uterine anomalies
- females with focal uterine lesions
- females who had previous ovarian surgeries
- females with history of previous exposure to radiotherapy , or chemotherapy
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 |
|---|---|---|
| Growth hormone (Norditropin, Novo nordisk) | Drug | The Antagonist protocol, The Long protocol, The Microflare protocol, The Short protocol |
Primary outcome
Numbers of oocytes retrieved and number of fertilized oocytes
Time frame: 2 years
Number of oocytes retrieved on the day of vaginal egg collection guided by trans vaginal ultrasound scan , 35 hours after hCG administration.
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 Oct 2015.
- Derived from this study: PubMed 26416521Dakhly DM, Bayoumi YA, Gad Allah SH. Which is the best IVF/ICSI protocol to be used in poor responders receiving growth hormone as an adjuvant treatment? A prospective randomized trial. Gynecol Endocrinol. 2016;32(2):116-9. doi: 10.3109/09513590.2015.1092136. Epub 2015 Sep 29.
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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.
Dina M Dakhly, MD principal investigator
Cairo University
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 Growth hormone (Norditropin, Novo nordisk) in people with Female Infertility Due to Diminished Ovarian Reserve, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
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 4 inclusion and 6 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 Oct 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 Egypt. 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?
Numbers of oocytes retrieved and number of fertilized oocytes (time frame: 2 years). 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 NCT01897324, which also lists 1 linked publication.
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 Oct 2015.