Ovarian Hyperstimulation SyndromePhase 1/2NCT01014104
Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome
A Phase 1/2 study testing Methylprednisolone in people with Ovarian Hyperstimulation Syndrome, run by Royan Institute at 1 site in Iran.
Trial summary
This study is a prospective randomized clinical controlled trial to assess the efficacy of the Methylprednisolone for preventing ovarian hyper stimulation syndrome in in vitro fertilization (IVF) cycles. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome
- What is being tested?
- Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 1 siteIran
- Study dates
- Oct 2009to Dec 2010
- Phase
- Phase 1/2
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Poly Cystic Ovarian Syndrome patients
- Indication for IVF/ICSI and Long Protocol ovarian stimulation
- Basal FSH≥10
- Normal BMI (20-25)
- physical health
Who cannot join
- Allergy to GnRH analogues, FSH and corticosteroids
- presence of heart failure, recent myocardial infarction
- Hypertension
- Diabetes mellitus
- epilepsy
- glaucoma
Show all 12Show fewer
- hypothyroidism
- hepatic failure
- osteoporosis
- peptic ulceration
- renal impairment
- Using drugs that have interaction with corticosteroids such
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome in In-vitro Fertilization Cycles: A Randomized Controlled Trial
This study is a prospective randomized clinical controlled trial to assess the efficacy of the Methylprednisolone for preventing ovarian hyper stimulation syndrome in in vitro fertilization (IVF) cycles.
Read the detailed description
Ovarian hyper stimulation syndrome is the most serious complication of ovarian stimulation which might be life threatening in the severe forms. Since there is still no definite cure for this syndrome, prevention is considered as an essential and vital issue. The objective of this study is to determine the effect of Methylprednisolone to prevent ovarian hyper stimulation syndrome in IVF cycles.
The study population comprises all infertile patients with diagnosis of polycystic ovarian syndrome which will undergo of in-vitro fertilization. The PCO subjects will be recognized based on the Rotterdam criteria inclusive the presence of least 2 signs of oligomenorrhea, hyper androgynism (clinical or laboratory), LH/FSH>2 and ovarian morphological evidences in Doppler ultrasound.
The existence of more than 20 follicles in both ovaries and E2 concentration >4000 pg/ml will be considered as the OHSS risk factors.
In this study all eligible patients will be randomly allocated into two study groups by a computerized randomization method:
Treatment group (case) will be administered 16 mg Methylprednisolone initiated from the first day of stimulation and will be tapered after the first pregnancy test (day 13 after the embryo transfer). Furthermore, these patients will receive a bolus IV dose methylprednisolone, 1g on the day of egg collection and embryo transfer.
Patients in the control group will not receive any treatment with glucocorticoids. If each group confronts with every kind of high risk signs or symptoms, they will undergo coasting or gonadotropin withdrawal or other treatment strategies.
The presence of OHSS is defined in accordance with the Golan 5 grade system and women who at least are at grade 2 of this classification (Mild) considered as OHSS cases and will experience abdominal distention and discomfort, nausea and vomiting and/or diarrhea and enlargement of ovaries(5-12cm). In Moderate forms, ultrasound evidences of ascites will be observed and severe OHSS accompany with clinical signs of ascites, hydrothorax, breathing disorders, hemoconcentration, coagulopathy and renal perfusion decrease.
- Conditions
- Ovarian Hyperstimulation Syndrome
- Being tested
- Methylprednisolone, Control
- Keywords
- Ovarian hyper stimulation syndrome, Methylprednisolone, IVF
- Medical subject headings
- Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Case
Administration of Methylprednisolone
ControlDrug
Normal salin injection
| Study group | Role | What they receive |
|---|---|---|
| Case | Experimental | Administration of Methylprednisolone Receives: Drug: Methylprednisolone |
| Control | Sham comparator | Not described Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence rate of Ovarian hyper stimulation syndrome
Measured: Until 20 days after embryos transfer
Secondary outcomes (5)
Estradiol concentration in the day before hCG administration
Measured: Until 20 days after embryos transfer
Retrieved and injected oocytes number and quality
Measured: Until 20 days after embryos transfer
Achieved and transferred embryos number and quality
Measured: Until 20 days after embryos transfer
Implantation rate
Measured: Until 20 days after embryos transfer
Chemical and clinical pregnancy rate and cancelation rate
Measured: Until 20 days after embryos transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionAug 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Hyperstimulation SyndromeStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Investigators
- Ashraf Moini, MD, Principal investigator, Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, IranMarzieh Shiva, MD, Principal investigator, Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, IranNarges bagheri lankarani, MD, Principal investigator, Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014104
- Sponsor's protocol ID
- Royan-Emb-005
- Status last verified
- Nov 2009
- First submitted
- 13 Nov 2009
- Last updated
- 15 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome in In-vitro Fertilization Cycles: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01014104
- Acronym / sponsor ID
- Royan-Emb-005
- Conditions
- Ovarian Hyperstimulation Syndrome
- Keywords
- Ovarian hyper stimulation syndrome, Methylprednisolone, IVF
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Oct 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Nov 2009 (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.
This study is a prospective randomized clinical controlled trial to assess the efficacy of the Methylprednisolone for preventing ovarian hyper stimulation syndrome in in vitro fertilization (IVF) cycles.
Detailed description
Ovarian hyper stimulation syndrome is the most serious complication of ovarian stimulation which might be life threatening in the severe forms. Since there is still no definite cure for this syndrome, prevention is considered as an essential and vital issue. The objective of this study is to determine the effect of Methylprednisolone to prevent ovarian hyper stimulation syndrome in IVF cycles.
The study population comprises all infertile patients with diagnosis of polycystic ovarian syndrome which will undergo of in-vitro fertilization. The PCO subjects will be recognized based on the Rotterdam criteria inclusive the presence of least 2 signs of oligomenorrhea, hyper androgynism (clinical or laboratory), LH/FSH>2 and ovarian morphological evidences in Doppler ultrasound.
The existence of more than 20 follicles in both ovaries and E2 concentration >4000 pg/ml will be considered as the OHSS risk factors.
In this study all eligible patients will be randomly allocated into two study groups by a computerized randomization method:
Treatment group (case) will be administered 16 mg Methylprednisolone initiated from the first day of stimulation and will be tapered after the first pregnancy test (day 13 after the embryo transfer). Furthermore, these patients will receive a bolus IV dose methylprednisolone, 1g on the day of egg collection and embryo transfer.
Patients in the control group will not receive any treatment with glucocorticoids. If each group confronts with every kind of high risk signs or symptoms, they will undergo coasting or gonadotropin withdrawal or other treatment strategies.
The presence of OHSS is defined in accordance with the Golan 5 grade system and women who at least are at grade 2 of this classification (Mild) considered as OHSS cases and will experience abdominal distention and discomfort, nausea and vomiting and/or diarrhea and enlargement of ovaries(5-12cm). In Moderate forms, ultrasound evidences of ascites will be observed and severe OHSS accompany with clinical signs of ascites, hydrothorax, breathing disorders, hemoconcentration, coagulopathy and renal perfusion decrease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | Experimental | Drug: MethylprednisoloneAdministration of Methylprednisolone |
| Control | Sham comparator | Drug: Control |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Poly Cystic Ovarian Syndrome patients
- Indication for IVF/ICSI and Long Protocol ovarian stimulation
- Basal FSH≥10
- Normal BMI (20-25)
- physical health
Key exclusion criteria (12 listed)
- Allergy to GnRH analogues, FSH and corticosteroids
- presence of heart failure, recent myocardial infarction
- Hypertension
- Diabetes mellitus
- epilepsy
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 |
|---|---|---|
| MethylprednisoloneAlso: CaseAdministration of Methylprednisolone | Drug | Case |
| ControlNormal salin injection | Drug | Control |
Primary outcome
Occurrence rate of Ovarian hyper stimulation syndrome
Time frame: Until 20 days after embryos transfer
5 secondary outcomes
Estradiol concentration in the day before hCG administration
Time frame: Until 20 days after embryos transfer
Retrieved and injected oocytes number and quality
Time frame: Until 20 days after embryos transfer
Achieved and transferred embryos number and quality
Time frame: Until 20 days after embryos transfer
Implantation rate
Time frame: Until 20 days after embryos transfer
Chemical and clinical pregnancy rate and cancelation rate
Time frame: Until 20 days after embryos transfer
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 15 Jul 2011.
- Related InfoLink provided by the sponsor.
Related trials for Ovarian Hyperstimulation Syndrome
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Clinical Study to Evaluate Efficacy of Cabergoline to Coasting in Reducing the Incidence of Ovarian Hyperstimulation Syndrome
Gynecologic Disease
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Real-world Evidence on Follitropin Delta Individual Dosing
Infertility, Sterility
Recruiting
Ovarian Hyperstimulation Syndrome Prevention
Ovarian Hyper Stimulation Syndrome (OHSS)
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.
Ashraf Moini, MD principal investigator
Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, Iran
Marzieh Shiva, MD principal investigator
Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, ACECR, Tehran, Iran
Narges bagheri lankarani, MD principal investigator
Endocrinology and Female Infertility Department, Reproductive Medicine Research Center, Royan institute, 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 1/2 study testing Methylprednisolone in people with Ovarian Hyperstimulation Syndrome, 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 5 inclusion and 12 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 15 Jul 2011. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Occurrence rate of Ovarian hyper stimulation syndrome (time frame: Until 20 days after embryos transfer). 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 15 Jul 2011.