Criteria for considering studies for this review

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1 Página 1 de 6 Ovulation induction in women with spontaneous premature ovarian failure [protocol] Kalantaridou SN, Calis KA, Nelson LM This protocol should be cited as: Kalantaridou SN, Calis KA, Nelson LM. Ovulation induction in women with spontaneous premature ovarian failure (Protocol for a Cochrane Review). In: The Cochrane Library, Issue 2, Oxford: Update Software. Background Premature ovarian failure (POF) is a condition characterized by amenorrhea, anovulation, sex steroid deficiency, and elevated serum gonadotropin levels in women less than 40 years of age (Rebar 1992; Nelson 1996). It affects 1% of women by the age of 40 (Coulam 1986). Young women can experience POF by several mechanisms, including karyotypic abnormalities, autoimmunity, radiation or chemotherapy, and surgical castration. In most cases the cause of premature ovarian failure is unknown (karyotypically normal spontaneous premature ovarian failure). Women with spontaneous POF have intermittent ovarian follicle function (Rebar 1992; Nelson 1994) and spontaneous pregnancies have occurred after the diagnosis of POF (Polansky 1976; Shangold 1977; Szlachter 1979; Aiman 1985; Ohsawa 1985; Alper 1986; Kreiner 1988). Attempts of ovulation induction in these patients using clomiphene citrate (Shapiro 1977), human menopausal gonadotropins (Johnson 1979), and combination of gonadotropin releasing hormone analogue with purified urinary FSH (Van Kasteren 1995) had no greater ovulation rates than those seen in untreated patients (Rebar 1992). Similarly, controlled studies showed no benefit using gonadotropin-releasing hormone analogue (Nelson 1992) or danazol (Anasti 1994). The aim of this review is to evaluate the evidence from randomized trials that ovulation induction can induce ovulation in women with spontaneous POF. Objectives To investigate whether the use of ovulation induction can induce significantly higher ovulation rates (principal outcome measure) in young women with POF compared with placebo or no treatment. Data on pregnancy rates, live birth rates, and miscarriage rates (secondary outcome measures) will be obtained if available. We will test the hypothesis that: "Ovulation induction (using clomiphene citrate, human menopausal gonadotropins, gonadotropin releasing hormone analogue, a combination of gonadotropin releasing hormone analogue with human menopausal gonadotropins, or other form of ovulation induction) can induce significantly higher ovulation rates in young women with POF compared with placebo or no treatment". Criteria for considering studies for this review Types of studies Studies will be considered for inclusion in this review if they evaluate ovulation rates in patients with karyotypically normal spontaneous POF failure undergoing ovulation induction (using clomiphene citrate, human menopausal gonadotropins, gonadotropin releasing hormone analogue, a combination of gonadotropin releasing hormone analogue with human menopausal gonadotropins, or other form of ovulation induction). Only randomized controlled studies will

2 Página 2 de 6 be considered suitable for inclusion. Types of participants Women with spontaneous POF undergoing ovulation induction in order to induce ovulation. Criteria for karyotypically normal spontaneous premature ovarian failure: 1. Age < 40 years 2. Two FSH levels > 40 miu/ml (at least one month apart) 3. Amenorrhea for at least 4 moths (not due to pregnancy) 4. No evidence of genetic, metabolic, toxic, or iatrogenic cause of the ovarian failure Types of intervention Randomized controlled studies comparing ovulation rates in women with POF will be considered suitable for inclusion in this review. Groups to be compared: women undergoing ovulation induction (using clomiphene citrate, human menopausal gonadotropins, gonadotropin releasing hormone analogue, a combination of gonadotropin releasing hormone analogue with human menopausal gonadotropins, or other form of ovulation induction) compared with control (placebo or no treatment). Types of outcome measures Studies will be considered suitable for inclusion in this review if they evaluate any of the following outcome measures: Primary outcome measure: Ovulation rates [midluteal serum progesterone levels >3 ng/ml (9.5 nmol/l) or in the luteal range for different laboratory asays]. Secondary outcome measures: Pregnancy rates (biochemical evidence of pregnancy, increase in serum beta-hcg levels; pregnancy confirmed by ultrasound); live birth rates; miscarriage rates. Search strategy for identification of studies The literature search will be limited initially to those studies reported in English. Trials reported in a foreign language will be sought over time as resources permit. All publications which describe randomized controlled trials investigating whether the use of ovulation induction can induce significantly higher ovulation rates (or pregnancy rates) in young women with POF compared with placebo or no treatment will be obtained using the search strategy developed by the Menstrual Disorders and Subfertility Group for MEDLINE and hand-searching of specialist journals and examination of review articles (see Review Group details for more information). The reviewers will also search the electronic database EMBASE. In addition, the following terms and variations of these terms will be included: premature ovarian failure premature menopause ovulation induction clomiphene citrate tamoxifen human menopausal gonadotropins gonadotropin releasing hormone analogue Reference lists of included and excluded studies will be inspected. Methods of the review

3 Página 3 de 6 The selection of trials for inclusion in the review will be undertaken by two reviewers (SNK and KAC) employing the search strategy described above. A third reviewer (LMN) will assess any trials where there will be uncertainty regarding eligibility. Any discrepancies will be resolved by discussion. An assessment of the quality of trials and data extraction will be performed independently by the reviewers (SNK, KAC, LMN) using forms designed according to the Cochrane guidelines. Where necessary, additional information on trial methodology or actual original trial data will be sought from the corresponding author of any trials that appear to meet the eligibility criteria. Statistical analysis will be performed in accordance with the guidelines for statistical analysis developed by the Menstrual Disorders and Subfertility Group. Heterogeneity between the results of different studies will be examined by inspecting the scatter in the data points and the overlap in their confidence intervals. Major quality criteria will be given a ranking to enable sensitivity analyses.included trials will be analyzed for the following quality criteria and methodological details: Method of randomization; blinding; number of patients randomized, excluded, or lost to follow up; reporting of the outcome of all the women enrolled and whether the trial was single or multicentered; the presence of power calculation; duration of the study; sources of any funding. Information on the trial participants included age, number of years since the development of ovarian failure, exclusion criteria. Interventions used: types of therapeutic agent used, and dose, duration, and timing of administration of therapeutic agents used. Information on clinical outcomes will be analyzed for ovulation rates (principal outcome measure), pregnancy rates, live birth rates, miscarriage rates (secondary outcome measures). Results from trials using different interventions will be analyzed separately. Sensitivity analysis will be performed according to randomization quality, control group comparison (either placebo or no treatment), equality at baseline, rate of withdrawal and losses to follow-up, intention to treat analysis and length of treatment period. For dichotomous data (for example, proportion of women with POF who ovulate), results for each study will be expressed as a odds ratio with 95% confidence intervals and will be combined for meta-analysis with RevMan software. If the randomized studies controlled studies have different length of therapy, subgroup analysis will be performed. We will combine placebo or no treatment studies. These studies will be analyzed separately as subgroups. This review will include trials that will be located up to April Subsequent eligible trials will be included in an update of this review. Acknowledgements Potential conflict of interest None known References Additional references

4 Página 4 de 6 Aiman 1985 Aiman J, Smentek C. Premature ovarian failure. Obstetrics and Gynecology 1985;66:9-14. Alper 1986 Alper MM, Jolly EE, Garner PR. Pregnancies after premature ovarian failure. Obstetrics and Gynecology 1986;7(Suppl): Anasti 1994 Anasti JN, Kimzey LM, Defensor RA, White B, Nelson LM. A controlled study of danazol for the treatment of karyotypically normal spontaneous premature ovarian failure. Fertility and Sterility 1994;62: Coulam 1986 Coulam CB, Adamson SC, Annegers JF. Incidence of premature ovarian failure. Obstetrics and Gynecology 1986;67: Johnson 1979 Johnson TR, Peterson EP. Gonadotropin induced pregnancy following "premature ovarian failure". Fertility and Sterility 1979;31: Kreiner 1988 Kreiner D, Droesch K, Navot D, Scott R, Rosenwaks Z. Spontaneous and pharmacologically induced remissions in patients with premature ovarian failure. Obstetrics and Gynecology 1988;73: Nelson 1992 Nelson LM, Kimzey LM, White BJ, Merriam GR. Gonadotropin suppression for the treatment of karyotypically normal spontaneous premature ovarian failure: a controlled trial. Fertility and Sterility 1992;57: Nelson 1994 Nelson LM, Anasti JN, Kimzey LM, Defensor RA, Lipetz KJ, White BJ, Shawker TH, Merino MJ. Development of luteinized graafian follicles in patients with karyotypically normal spontaneous premature ovarian failure. Journal of Clinical Endocrinology and Metabolism 1994;79: Nelson 1996 Nelson LM, Anasti JN, Flack MR. Premature ovarian failure. In: Adashi EY, Rock JA, Rozenwaks Z, editor(s). Reproductive endocrinology, surgery and technology 1st Edition. Philadelphia: Lippincott-Raven, 1996: Ohsawa 1985 Ohsawa M, Wu MC, Masahashi T, Asai M, Narita O. Cyclic therapy resulted in pregnancy in premature ovarian failure. Obstetrics and Gynecology 1985;66(3 Suppl):64-67.

5 Página 5 de 6 Polansky 1976 Polansky S, DePapp EW. Pregnancy associated with hypergonadotropic hypogonadism. Obstetrics and Gynecology 1976;47(Suppl): Rebar 1992 Rebar RW, Cedars MI. Hypergonadotropic forms of amenorrhea in young women. Endocrinology and Metabolism Clinics of North America 1992;21: Shangold 1977 Shangold MM, Turksoy RN, Bashford RA, Hammond CB. Pregnancy following the "insensitive ovary syndrome". Fertility and Sterility 1977;28: Shapiro 1977 Shapiro AG, Rubin A. Spontaneous pregnancy in association with hypergonadotropic ovarian failure. Fertility and Sterility 1977;28: Szlachter 1979 Szlachter BN, Nachtigall LE, Epstein J, Young BK, Weiss G. Premature menopause: a reversible entity?. Obstetrics and Gynecology 1979;54: Van Kasteren 1995 Van Kasteren YM, Hoek A, Schoemaker J. Ovulation induction in premature ovarian failure: A placebo-controlled randomized trial combining pituitary suppression with gonadotropin stimulation. Fertility and Sterility 1995;64: Cover sheet Ovulation induction in women with spontaneous premature ovarian failure Reviewer(s) Contribution of Reviewer(s) Kalantaridou SN, Calis KA, Nelson LM Sophia N. Kalantaridou: Took the lead in writing the protocol, developed objectives, selection criteria, methods and background. Karim A. Calis: Contributed to background section. Developed and performed search strategy. Lawrence M. Nelson: Conceptualised and edited the protocol. Issue protocol first published Date of last minor amendment 2001 issue 3 Information not supplied by reviewer

6 Página 6 de 6 Date of last substantive amendment Most recent changes Review expected to be published in: Contact address Cochrane Library number Editorial group Editorial group code 31 May 2001 Information not supplied by reviewer Issue 3, 2003 Ms Sophia Kalantaridou Kosti Palama 3 Ioannini GREECE 5042 Telephone: Facsimile: Kalantas@exchange.nih.gov CD Cochrane Menstrual Disorders and Subfertility Group MENSTR Additional tables Additional tables are not available for this protocol Print Close

Hormone replacement therapy in young women with karyotypically normal spontaneous premature ovarian failure [protocol]

Página 1 de 7 Hormone replacement therapy in young women with karyotypically normal spontaneous premature ovarian failure [protocol] Kalantaridou SN, Calis KA, Nelson LM. This protocol should be cited