In Vitro FertilizationPhase 2/3NCT02993588
Impact of Melatonin on IVF/ICSI Outcomes in Prospective Poor Responders
A Phase 2/3 study testing Melatonin in people with In Vitro Fertilization and Poor Ovarian Response, run by Assiut University at 2 sites in Egypt.
Trial summary
The purpose of this study is to investigate the impact of melatonin administration on in vitro fertilization (IVF/ICSI) outcomes namely the total number and quality of the oocytes and embryos in the prospective poor responders. Read more about this study
- Who is it for?
- Ages 30 to 42 years, women only
- Conditions the study is for
- In Vitro Fertilization, Poor Ovarian Response
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- Dec 2016to Aug 2017
- 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 30 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Prospective poor responder with AMH < 1 ng/ml and AFC < 8 (in both ovaries).
Who cannot join
- Severe male factor infertility.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Osama Abdalmageed
Asyut, Asyut Governorate, 71515
Osama Abdalmageed, 1007972027, drosamast@yahoo.com.au
Osama Abdalmageed, 1007972027 ext. Abdalmageed
- Recruiting
Osama Abdalmageed
Asyut, Non-US/Non-Canadian, 71111
Osama Abdalmageed, MD, 1007972027, drosamast1981@gmail.com
Osama Abdalmageed, 1007972027, drosamast1981@gmail.com
About this study
Official title: Impact of Melatonin Adjuvant Therapy on IVF/ICSI Outcomes in Prospective Poor Responders: A Double-blind, Randomized, Placebo-controlled Trial
The purpose of this study is to investigate the impact of melatonin administration on in vitro fertilization (IVF/ICSI) outcomes namely the total number and quality of the oocytes and embryos in the prospective poor responders.
Read the detailed description
The prospective poor responders have been associated with lower number and poorer oocyte quality. Melatonin is suggested to have antioxidative effects which may contribute to improving the IVF/ICSI outcomes in this group of patients who expected to have poor outcomes. However, the expected beneficial effects of melatonin have not yet been investigated. The purpose of this study is to investigate the impact of melatonin administration on IVF/ICSI outcomes namely the total number and quality of the oocytes and embryos in the prospective poor responders. A randomized, double-blinded, placebo-controlled study is used to investigate the impact of melatonin on the IVF/ICSI outcomes.
- Conditions
- In Vitro Fertilization, Poor Ovarian Response
- Being tested
- Melatonin, Placebo
- Keywords
- Melatonin, IVF/ICSI, Poor ovarian response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Melatonin 6 mg tablet once daily
PlaceboOther
one tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | Melatonin 6 mg tablet once daily. Receives: Drug: Melatonin |
| Placebo | Placebo comparator | Placebo tablet once daily Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of retrieved mature oocytes
Measured: On the day of oocyte retrieval procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionAug 2017 (estimated)
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 In Vitro FertilizationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Saber Thabet Abdalmageed, Assiut University
- Investigators
- Osama Abdalmageed, MD, Principal investigator, Women health center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993588
- Sponsor's protocol ID
- Melatonin RCT
- Status last verified
- Dec 2016
- First submitted
- 13 Dec 2016
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The data will be kept with the study team only and it is not allowed by our institution regulations to share the data.
Publications
Fernando S, Rombauts L. Melatonin: shedding light on infertility?--A review of the recent literature. J Ovarian Res. 2014 Oct 21;7:98. doi: 10.1186/s13048-014-0098-y.
PubMed 25330986
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Melatonin Adjuvant Therapy on IVF/ICSI Outcomes in Prospective Poor Responders: A Double-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02993588
- Acronym / sponsor ID
- Melatonin RCT
- Conditions
- In Vitro Fertilization, Poor Ovarian Response
- Keywords
- Melatonin, IVF/ICSI, Poor ovarian response
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Aug 2017 (estimated)
- First posted
- 15 Dec 2016 (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.
The purpose of this study is to investigate the impact of melatonin administration on in vitro fertilization (IVF/ICSI) outcomes namely the total number and quality of the oocytes and embryos in the prospective poor responders.
Detailed description
The prospective poor responders have been associated with lower number and poorer oocyte quality. Melatonin is suggested to have antioxidative effects which may contribute to improving the IVF/ICSI outcomes in this group of patients who expected to have poor outcomes. However, the expected beneficial effects of melatonin have not yet been investigated. The purpose of this study is to investigate the impact of melatonin administration on IVF/ICSI outcomes namely the total number and quality of the oocytes and embryos in the prospective poor responders. A randomized, double-blinded, placebo-controlled study is used to investigate the impact of melatonin on the IVF/ICSI outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Drug: MelatoninMelatonin 6 mg tablet once daily. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo tablet once daily |
Who may qualify
- Ages
- 30 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Prospective poor responder with AMH < 1 ng/ml and AFC < 8 (in both ovaries).
Key exclusion criteria (1 listed)
- Severe male factor infertility.
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 |
|---|---|---|
| MelatoninMelatonin 6 mg tablet once daily | Drug | Melatonin |
| Placeboone tablet once daily | Other | Placebo |
Primary outcome
Total number of retrieved mature oocytes
Time frame: On the day of oocyte retrieval procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
- Background: PubMed 25330986Fernando S, Rombauts L. Melatonin: shedding light on infertility?--A review of the recent literature. J Ovarian Res. 2014 Oct 21;7:98. doi: 10.1186/s13048-014-0098-y.
- Individual participant dataSharing planned: No. The data will be kept with the study team only and it is not allowed by our institution regulations to share the data.
Related trials for In Vitro Fertilization
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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.
Osama Abdalmageed, MD principal investigator
Women health center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Melatonin in people with In Vitro Fertilization and Poor Ovarian Response, run by Assiut University at 2 sites 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 1 inclusion and 1 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 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Contact Osama Abdalmageed, MD (1007972027, drosamast1981@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of retrieved mature oocytes (time frame: On the day of oocyte retrieval procedure). 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 NCT02993588, 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 15 Dec 2016.