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| ID | Type | Description | Link |
|---|---|---|---|
| kmsalama | Registry Identifier | khalid |
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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
The current study is conducted at Assisted Reproduction Unit at Almana general Hospital, kingdom of saudi arabia.and other private centers in Egypt. The study protocol was approved by the Local Ethical Committee. The study aimed to include women suspected to be at high risk for development of OHSS during agonist ovarian stimulation protocol.The study includes only women of couples singed written consent to participate in the study, to undergo embryo freezing and to postpone for transfer of cryopreserved embryo.
All patients are clinically evaluated for the presence of abdominal pain and if present will be graduated using a numerical pain visual analogue scale (VAS) with 0 means no pain and 10 means severe intolerable pain. Patients are evaluated for the presence of nausea and/or vomiting and sense of abdominal distension. Symptoms are scored using verbal analogue scale as nil, mild, moderate, and severe symptom. Blood samples are obtained under complete aseptic condition for estimation of serum E2 level and determination of hematocrit value (Ht%) and total leucocytic count (TLC).
Then, all patients underwent ultrasound scanning for estimation of ovarian measurements that were represented as the maximal ovarian diameter (MOD) and for ascites grading if present. Ultrasound scanning is performed using a 5 megahertz vaginal probe , otherwise a 3.5 megahertz, 2.6 megahertz or 5megahertz abdominal probe is used if visualization using a vaginal probe is compromised. Ascites is graded according to the quantity of fluid accumulation in the peritoneal cavity with the patient in the anti-Trendelenburg position.
Women fulfilling inclusion criteria were randomely allocated,using sealed envelops, into two equal groups. Group with embryo freezing alone (Control group) or while the other group additionally receives cetrotide subcutaneous injection in a daily dose of 0.25 mg started on day of oocyte retrieval for 3 days (Study group). Symptomatic treatment for associated symptoms as analgesics, antiemetics and antispasmodics are also prescribed. Patients are categorized according to classification grading of OHSS.
Class Clinical features Biochemical features
Mild - Abdominal distension/ discomfort
Moderate - Mild features plus
Severe - Mild & Moderate features plus
Critical - Severe features plus
findings seen with severe OHSS
US: Ultrasound; Ht%:Ht; Hematocrit value; TLC: Total leucocytic count: ARDS; adult respiratory distress syndrome.
All patients are managed as outpatients unless management of severe symptoms necessitated hospital admission. Pain scores, serum E2 levels and MOD are evaluated daily. Patients are evaluated for associated symptoms previously determined during clinical evaluation, ascites grading and TLC and Ht value were evaluated at 3 and 6 days and on end of the trial on the 8th day after oocyte retrieval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cetrotide | Active Comparator | 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 cetrotide | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetrorelix | Drug | study group received 3-day Cetrorelix 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 control (24 patients) did not receive Cetrorelix Acetate. Grading were re-evaluated on Day-3, 6 and 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Serum E2 Levels | Serum E2 levels (Serum E2 level in picograms/ml) were evaluated daily. | 8 days |
| Daily Maximal Ovarian Diameter | MOD (maximal ovarian diameter in mm) were evaluated daily. | 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Numerical Pain Visual Analogue Scale Score | -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 . | 8 days. |
| Daily Hematocrits Value |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy | -severity grades of gastrointestinal manifestations determined at Day -0,Day -3 and Day -6. | 0-6 days |
Inclusion Criteria:
Exclusion Criteria:
1- Absence of one or more of the items of the inclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| khalid M salama, MD | Benha University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benha university hospitalا | Banhā | El Qalubia | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1026900 | Background | Scott J, Huskisson EC. Graphic representation of pain. Pain. 1976 Jun;2(2):175-84. No abstract available. | |
| 17908403 | Background | Lainas TG, Sfontouris IA, Zorzovilis IZ, Petsas GK, Lainas GT, Kolibianakis EM. Management of severe early ovarian hyperstimulation syndrome by re-initiation of GnRH antagonist. Reprod Biomed Online. 2007 Oct;15(4):408-12. doi: 10.1016/s1472-6483(10)60366-5. |
| Label | URL |
|---|---|
| infertility | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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(maximal ovarian diameter) 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Daily Serum E2 Levels | Serum E2 levels (Serum E2 level in picograms/ml) were evaluated daily. | Posted | Mean | Standard Deviation | picograms/ml | 8 days |
|
one month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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no Limitations and Caveats
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| dr khalid M Salama | Benha university | 01225861026 | dr.khalid_sleem@yahoo.com |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C062876 | cetrorelix |
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|
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Blood samples were obtained under complete aseptic condition for determination of hematocrits value (Ht%) |
| 0-8 days. |
| Ultrasound Detected Severity Grades of Ascites From Days 0-8 | -US detected severity grades of ascites determined at Day -0, Day -3 and Day -8. | 0-8 days |
| Daily Total Leucocytic Count | TLC(x 1ooo cells/ml) | 0 -8days. |
| 9130900 | Background | Albano C, Smitz J, Camus M, Riethmuller-Winzen H, Van Steirteghem A, Devroey P. Comparison of different doses of gonadotropin-releasing hormone antagonist Cetrorelix during controlled ovarian hyperstimulation. Fertil Steril. 1997 May;67(5):917-22. doi: 10.1016/s0015-0282(97)81407-0. |
| 1633889 | Background | Navot D, Bergh PA, Laufer N. Ovarian hyperstimulation syndrome in novel reproductive technologies: prevention and treatment. Fertil Steril. 1992 Aug;58(2):249-61. doi: 10.1016/s0015-0282(16)55188-7. |
| 29132339 | Derived | Salama 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. |
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Daily Maximal Ovarian Diameter | MOD (maximal ovarian diameter in mm) were evaluated daily. | Posted | Mean | Standard Deviation | mm | 8 days |
|
|
|
|
| Secondary | Daily Numerical Pain Visual Analogue Scale Score | -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 . | Posted | Mean | Standard Deviation | units on a scale | 8 days. |
|
|
|
|
| Secondary | Daily Hematocrits Value | Blood samples were obtained under complete aseptic condition for determination of hematocrits value (Ht%) | Posted | Mean | Standard Deviation | percentge | 0-8 days. |
|
|
|
| Secondary | Ultrasound Detected Severity Grades of Ascites From Days 0-8 | -US detected severity grades of ascites determined at Day -0, Day -3 and Day -8. | Posted | Number | US detected ascitis | 0-8 days |
|
|
|
| Secondary | Daily Total Leucocytic Count | TLC(x 1ooo cells/ml) | Posted | Mean | Standard Deviation | 1000 cells/ml | 0 -8days. |
|
|
|
| Other Pre-specified | Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy | -severity grades of gastrointestinal manifestations determined at Day -0,Day -3 and Day -6. | Posted | Number | GI manifestations | 0-6 days |
|
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | 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. | 0 | 24 | 0 | 24 | 0 | 24 |
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| Day-2 |
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| Day-3 |
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| Day-4 |
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| Day-5 |
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| Day-6 |
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| Day-7 |
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| Day-8 |
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| Day-2 |
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| Day-3 |
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| Day-4 |
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| Day-5 |
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| Day-6 |
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| Day-7 |
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| Day-8 |
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| Day-6 |
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| Day-8 |
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| Low grade ascitis at Day-8 |
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| moderate grade ascitis at Day-0 |
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| moderate grade ascitis at Day-3 |
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| moderate grade ascitis at Day-8 |
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| severe grade ascitis at Day-0 |
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| severe grade ascitis at Day-3 |
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| severe grade ascitis at Day-8 |
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| Day-6 |
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| Day-8 |
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| moderate Nausea at Day-0 |
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| severe Nausea at Day-0 |
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| Nil Nausea at Day-3 |
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| mild Nausea at Day-3 |
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| moderate Nausea at Day-3 |
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| severe Nausea at Day-3 |
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| Nil Nausea at Day-6 |
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| mild Nausea at Day-6 |
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| moderate Nausea at Day-6 |
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| severe Nausea at Day-6 |
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| Nil Vomiting at Day-0 |
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| mild Vomiting at Day-0 |
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| moderatel Vomiting at Day-0 |
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| severe Vomiting at Day-0 |
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| Nil Vomiting at Day-3 |
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| mild Vomiting at Day-3 |
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| moderate Vomiting at Day-3 |
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| severe Vomiting at Day-3 |
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| Nil Vomiting at Day-6 |
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| mild Vomiting at Day-6 |
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| moderat Vomiting at Day-6 |
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| severe Vomiting at Day-6 |
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| Nil Abdominal distension at Day-0 |
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| mild Abdominal distension at Day-0 |
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| moderate Abdominal distension at Day-0 |
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| severe Abdominal distension at Day-0 |
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| Nil Abdominal distension at Day-3 |
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| mild Abdominal distension at Day-3 |
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| moderate Abdominal distension at Day-3 |
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| severe Abdominal distension at Day-3 |
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| Nil Abdominal distension at Day-6 |
|
| mild Abdominal distension at Day-6 |
|
| moderate Abdominal distension at Day-6 |
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| severe Abdominal distension at Day-6 |
|