Primary outcomeMean· 8 days
Daily Serum E2 Levels
| Group | Value (picograms/ml) | Spread |
|---|---|---|
| Cetrotide | 4761 | 940 |
| no Cetrotide | 5004 | 792 |
Trial · Interventional
Status unknownPhase 2/3Results postedRegistry dataOutcome of Cetrotide Therapy for Management of Women at High-risk of Ovarian Hyperstimulation Syndrome
Overview
- Status
- Status unknown
- Phase
- Phase 2/3
- Enrollment
- 48 participants (actual)
- Sponsor
- Benha University · Other
- Design
- Randomized · Triple masking
- Countries
1 country
Egypt
- Start
- Oct 2014
- Primary completion
- Apr 2017 (estimated)
- Completion
- May 2017 (estimated)
- First posted
- 6 Jul 2016 (estimated)
- Last update posted
- 30 Mar 2017
- Conditions
- Infertility
Timeline
1 trial · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20142015201620172018
- Ph 2/3
Outcome of Cetrotide Therapy for Management of Women at High-risk of Ovarian Hyperstimulation Syndrome
NCT02823080Oct 2014 to est. May 2017
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
To evaluate safety and efficacy of 3-day cetrotide therapy started on day of oocyte retrieval (Day-0) in women at high-risk for development of ovarian hyperstimulation syndrome (OHSS) after gonadotropin- releasing hormon agonist induction protocol. Patients \& Methods: Forty-eight women fulfilling inclusion criteria underwent ultrasound scanning for maximal ovarian diameter (MOD) estimation and ascites grading. Patients underwent embryo freezing, but study group received 3-day Cetrotide sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8
Interventions
- CetrorelixDrug
Arms2
Active comparator
cetrotide
study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
No intervention
no cetrotide
control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
Primary outcomes2
Outcomes the sponsor listed as primary.
Daily Serum E2 Levels
Time frame · 8 days
Registry description
Serum E2 levels (Serum E2 level in picograms/ml) were evaluated daily.
Daily Maximal Ovarian Diameter
Time frame · 8 days
Registry description
MOD (maximal ovarian diameter in mm) were evaluated daily.
Secondary outcomes(4)
Daily Numerical Pain Visual Analogue Scale Score
Time frame · 8 days.
Registry description
-All patients were clinically evaluated for the presence of abdominal pain and if present was graduated using a numerical pain visual analogue scale (VAS) with 0 means no pain and 10 means severe intolerable pain .
Daily Hematocrits Value
Time frame · 0-8 days.
Registry description
Blood samples were obtained under complete aseptic condition for determination of hematocrits value (Ht%)
Ultrasound Detected Severity Grades of Ascites From Days 0-8
Time frame · 0-8 days
Registry description
-US detected severity grades of ascites determined at Day -0, Day -3 and Day -8.
Daily Total Leucocytic Count
Time frame · 0 -8days.
Registry description
TLC(x 1ooo cells/ml)
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· 8 days
Daily Maximal Ovarian Diameter
| Group | Value (mm) | Spread |
|---|---|---|
| Cetrotide | 9.4 | 4.5 |
| no Cetrotide | 10.4 | 5.8 |
Secondary and other outcome results(5)
Secondary outcomeMean· 8 days.
Daily Numerical Pain Visual Analogue Scale Score
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Cetrotide | 5.3 | 1.6 |
| no Cetrotide | 5.4 | 1.7 |
Secondary outcomeMean· 0-8 days.
Daily Hematocrits Value
| Group | Value (percentge) | Spread |
|---|---|---|
| Cetrotide | 42.2 | 5.2 |
| no Cetrotide | 39.8 | 4.2 |
Secondary outcomeNumber· 0-8 days
Ultrasound Detected Severity Grades of Ascites From Days 0-8
| Group | Value (US detected ascitis) |
|---|---|
| Cetrotide | 8 |
| no Cetrotide | 6 |
Secondary outcomeMean· 0 -8days.
Daily Total Leucocytic Count
| Group | Value (1000 cells/ml) | Spread |
|---|---|---|
| Cetrotide | 12.75 | 3.1 |
| no Cetrotide | 11.6 | 3.7 |
Other pre specified outcomeNumber· 0-6 days
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
| Group | Value (GI manifestations) |
|---|---|
| Cetrotide | 5 |
| no Cetrotide | 6 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Cetrotidestudy group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8. | 0 / 24 | 0 / 24 | 0 / 24 |
| no Cetrotidecontrol group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8. | 0 / 24 | 0 / 24 | 0 / 24 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
PubMed tag: none · 1997
7 results
Comparison of different doses of gonadotropin-releasing hormone antagonist Cetrorelix during controlled ovarian hyperstimulation.
Albano et al. 1997Fertility and sterilitycited by 150
PMID 9130900DOI 10.1016/s0015-0282(97)81407-0PUB-09130900
Full text at the publisher7 results
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedSalama KM, Abo Ragab HM, El Sherbiny MF, Morsi AA, Souidan II. Sequential E2 levels not ovarian maximal diameter estimates were correlated with outcome of cetrotide therapy for management of women at high-risk of ovarian hyperstimulation syndrome: a randomized controlled study. BMC Womens Health. 2017 Nov 13;17(1):108. doi: 10.1186/s12905-017-0466-z. PMID 29132339
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 20 Years up to 35 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1. number of retrieved oocytes was ≥20
2. mean number of follicles with a diameter of \>16 mm was ≥18
3. serum E2 concentrations of ≥3500 pg/ml
4. ovarian diameter on the day of ovum retrieval of \>10 cm
5. presentation of evident symptoms of OHSS on the day of aspiration .
Exclusion Criteria:
1- Absence of one or more of the items of the inclusion criteria.
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