Ovarian Hyperstimulation SyndromePhase 2NCT04351126
Management of Ovarian Hyperstimulation Syndrome as a State of Defective Mineralocorticoid Response
A Phase 2 study testing Fludrocortisone 0.1 Milligrams (mg) and Bromocriptine in people with Ovarian Hyperstimulation Syndrome, run by Ganin Fertility Center at 1 site in Egypt.
Trial summary
lines of evidence that support nature of ovarian hyperstimulation syndrome (OHSS) as "defective mineralocorticoid response" are cited, our hypothesis is tested clinically in both prophylaxis against and treatment of OHSS. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome
- What is being tested?
- Fludrocortisone 0.1 Milligrams (mg) and Bromocriptine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 29 Feb 2020
- Phase
- Phase 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- retrieval of less than 20 oocytes
- age less than 18 or above 40
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pathophysiology and Nature of Ovarian Hyperstimulation Syndrome (OHSS) as a Clinical Entity Could be Fully Explained and Effectively Managed as a State of Defective Mineralocorticoid Response
lines of evidence that support nature of ovarian hyperstimulation syndrome (OHSS) as "defective mineralocorticoid response" are cited, our hypothesis is tested clinically in both prophylaxis against and treatment of OHSS.
Read the detailed description
several studies state significant correlation between OHSS and activation of Renin-angiotensin-aldosterone system (RAAS), degree of activation of RAAS correlates with severity of OHSS. In OHSS there is a cascade of events that mainly involves capillary leak with resultant fluid shift and electrolytes imbalance, these consequences are more pronounced - according to our hypothesis - due to inadequate mineralocorticoid response/activity in susceptible individuals in the settings of high progesterone levels with its antimineralocorticoid property, OHSS can be interpreted as a (mineralocorticoid deficiency crisis) and may effectively be treated as being so, so we conducted this study to test the hypothesis in both treatment and prevention of OHSS.
- Conditions
- Ovarian Hyperstimulation Syndrome
- Being tested
- Fludrocortisone 0.1 Milligrams (mg), Bromocriptine
- Keywords
- OHSS, Mineralocorticoid, aldosterone
- 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.
Fludrocortisone 0.1 Milligrams (mg)Drug
0.2-0.6 mg/day of fludrocortisone is prescribed
BromocriptineDrug
2.5 mg prescribed Vaginally twice daily
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | patients at high risk for OHSS who are receiving conventional treatment either as a prophylaxis (in the form of bromocriptine) or as a management in case of developing OHSS (as continual bromocriptine and fluid monitoring and or paracentesis and or tube thoracostomy) Receives: Drug: Bromocriptine |
| treatment group | Experimental | patient who has developed OHSS while on conventional lines of management (as continual bromocriptine and fluid monitoring and or paracentesis and or tube thoracostomy) patients in this group, fludrocortisone was added to conventional lines of management. Receives: Drug: Fludrocortisone 0.1 Milligrams (mg); Drug: Bromocriptine |
| prevention group | Experimental | patients at high risk for OHSS who are receiving fludrocortisone as a prophylaxis Receives: Drug: Fludrocortisone 0.1 Milligrams (mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of recovery
Time needed for full clinical recovery
Measured: 10 days
prevention of OHSS occurrence
percentage of cases that has developed OHSS in both control and prevention groups
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Apr 2019
- Primary completion25 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ganin Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad saber mahmoud sayed zeafan, Ganin Fertility Center
- Investigators
- Muhammad S Zeafan, MBBCH, Principal investigator, Ganin Fertility Centerkhaled M Elqusi, BSc, Principal investigator, Ganin Fertility CenterHossam Elattar, MBBCH, Principal investigator, Ganin Fertility CenterHosam Zaki, MSc, FRCOG, Study director, Ganin Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351126
- Sponsor's protocol ID
- MSM-01
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Navot D, Margalioth EJ, Laufer N, Birkenfeld A, Relou A, Rosler A, Schenker JG. Direct correlation between plasma renin activity and severity of the ovarian hyperstimulation syndrome. Fertil Steril. 1987 Jul;48(1):57-61. doi: 10.1016/s0015-0282(16)59290-5.
PubMed 2439386Delbaere A, Bergmann PJ, Englert Y. Features of the Renin-angiotensin system in ascites and pleural effusion during severe ovarian hyperstimulation syndrome. J Assist Reprod Genet. 1997 May;14(5):241-4. doi: 10.1007/BF02765823.
PubMed 9147235Gomez-Sanchez E, Gomez-Sanchez CE. The multifaceted mineralocorticoid receptor. Compr Physiol. 2014 Jul;4(3):965-94. doi: 10.1002/cphy.c130044.
PubMed 24944027Dunne FP, Barry DG, Ferriss JB, Grealy G, Murphy D. Changes in blood pressure during the normal menstrual cycle. Clin Sci (Lond). 1991 Oct;81(4):515-8. doi: 10.1042/cs0810515.
PubMed 1657498Ujioka T, Matsuura K, Kawano T, Okamura H. Role of progesterone in capillary permeability in hyperstimulated rats. Hum Reprod. 1997 Aug;12(8):1629-34. doi: 10.1093/humrep/12.8.1629.
PubMed 9308783Lainas T, Petsas G, Stavropoulou G, Alexopoulou E, Iliadis G, Minaretzis D. Administration of methylprednisolone to prevent severe ovarian hyperstimulation syndrome in patients undergoing in vitro fertilization. Fertil Steril. 2002 Sep;78(3):529-33. doi: 10.1016/s0015-0282(02)03290-9.
PubMed 12215328Kim MK, Won HJ, Shim SH, Cha DH, Yoon TK. Spontaneous ovarian hyperstimulation syndrome following a thawed embryo transfer cycle. Clin Exp Reprod Med. 2014 Sep;41(3):140-5. doi: 10.5653/cerm.2014.41.3.140. Epub 2014 Sep 30.
PubMed 25309860
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiology and Nature of Ovarian Hyperstimulation Syndrome (OHSS) as a Clinical Entity Could be Fully Explained and Effectively Managed as a State of Defective Mineralocorticoid Response
- ClinicalTrials.gov ID
- NCT04351126
- Acronym / sponsor ID
- MSM-01
- Conditions
- Ovarian Hyperstimulation Syndrome
- Keywords
- OHSS, Mineralocorticoid, aldosterone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Ganin Fertility CenterUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 17 Apr 2020 (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.
lines of evidence that support nature of ovarian hyperstimulation syndrome (OHSS) as "defective mineralocorticoid response" are cited, our hypothesis is tested clinically in both prophylaxis against and treatment of OHSS.
Detailed description
several studies state significant correlation between OHSS and activation of Renin-angiotensin-aldosterone system (RAAS), degree of activation of RAAS correlates with severity of OHSS. In OHSS there is a cascade of events that mainly involves capillary leak with resultant fluid shift and electrolytes imbalance, these consequences are more pronounced - according to our hypothesis - due to inadequate mineralocorticoid response/activity in susceptible individuals in the settings of high progesterone levels with its antimineralocorticoid property, OHSS can be interpreted as a (mineralocorticoid deficiency crisis) and may effectively be treated as being so, so we conducted this study to test the hypothesis in both treatment and prevention of OHSS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Drug: Bromocriptinepatients at high risk for OHSS who are receiving conventional treatment either as a prophylaxis (in the form of bromocriptine) or as a management in case of developing OHSS (as continual bromocriptine and fluid monitoring and or paracentesis and or tube thoracostomy) |
| treatment group | Experimental | Drug: Fludrocortisone 0.1 Milligrams (mg), Drug: Bromocriptinepatient who has developed OHSS while on conventional lines of management (as continual bromocriptine and fluid monitoring and or paracentesis and or tube thoracostomy) patients in this group, fludrocortisone was added to conventional lines of management. |
| prevention group | Experimental | Drug: Fludrocortisone 0.1 Milligrams (mg)patients at high risk for OHSS who are receiving fludrocortisone as a prophylaxis |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- retrieval of less than 20 oocytes
- age less than 18 or above 40
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 |
|---|---|---|
| Fludrocortisone 0.1 Milligrams (mg)0.2-0.6 mg/day of fludrocortisone is prescribed | Drug | prevention group, treatment group |
| Bromocriptine2.5 mg prescribed Vaginally twice daily | Drug | Control group, treatment group |
Primary outcome
duration of recovery
Time frame: 10 days
Time needed for full clinical recovery
prevention of OHSS occurrence
Time frame: 21 days
percentage of cases that has developed OHSS in both control and prevention groups
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 17 Apr 2020.
- Background: PubMed 2439386Navot D, Margalioth EJ, Laufer N, Birkenfeld A, Relou A, Rosler A, Schenker JG. Direct correlation between plasma renin activity and severity of the ovarian hyperstimulation syndrome. Fertil Steril. 1987 Jul;48(1):57-61. doi: 10.1016/s0015-0282(16)59290-5.
- Background: PubMed 9147235Delbaere A, Bergmann PJ, Englert Y. Features of the Renin-angiotensin system in ascites and pleural effusion during severe ovarian hyperstimulation syndrome. J Assist Reprod Genet. 1997 May;14(5):241-4. doi: 10.1007/BF02765823.
- Background: PubMed 24944027Gomez-Sanchez E, Gomez-Sanchez CE. The multifaceted mineralocorticoid receptor. Compr Physiol. 2014 Jul;4(3):965-94. doi: 10.1002/cphy.c130044.
- Background: PubMed 1657498Dunne FP, Barry DG, Ferriss JB, Grealy G, Murphy D. Changes in blood pressure during the normal menstrual cycle. Clin Sci (Lond). 1991 Oct;81(4):515-8. doi: 10.1042/cs0810515.
- Background: PubMed 9308783Ujioka T, Matsuura K, Kawano T, Okamura H. Role of progesterone in capillary permeability in hyperstimulated rats. Hum Reprod. 1997 Aug;12(8):1629-34. doi: 10.1093/humrep/12.8.1629.
- Background: PubMed 12215328Lainas T, Petsas G, Stavropoulou G, Alexopoulou E, Iliadis G, Minaretzis D. Administration of methylprednisolone to prevent severe ovarian hyperstimulation syndrome in patients undergoing in vitro fertilization. Fertil Steril. 2002 Sep;78(3):529-33. doi: 10.1016/s0015-0282(02)03290-9.
- Background: PubMed 25309860Kim MK, Won HJ, Shim SH, Cha DH, Yoon TK. Spontaneous ovarian hyperstimulation syndrome following a thawed embryo transfer cycle. Clin Exp Reprod Med. 2014 Sep;41(3):140-5. doi: 10.5653/cerm.2014.41.3.140. Epub 2014 Sep 30.
- Individual participant dataSharing planned: No
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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.
Muhammad S Zeafan, MBBCH principal investigator
Ganin Fertility Center
khaled M Elqusi, BSc principal investigator
Ganin Fertility Center
Hossam Elattar, MBBCH principal investigator
Ganin Fertility Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fludrocortisone 0.1 Milligrams (mg) and Bromocriptine in people with Ovarian Hyperstimulation Syndrome, run by Ganin Fertility Center 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 0 inclusion and 2 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 17 Apr 2020. 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 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?
duration of recovery (time frame: 10 days). The study lists 2 primary outcomes in all. 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 NCT04351126, which also lists 7 linked publications.
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 17 Apr 2020.